Showing papers in "Diabetes Care in 2003"

Economic costs of diabetes in the US in 2002.

Abstract: Objective Diabetes is the fifth leading cause of death by disease in the U.S. Diabetes also contributes to higher rates of morbidity-people with diabetes are at higher risk for heart disease, blindness, kidney failure, extremity amputations, and other chronic conditions. The objectives of this study were 1). to estimate the direct medical and indirect productivity-related costs attributable to diabetes and 2). to calculate and compare the total and per capita medical expenditures for people with and without diabetes. Research design and methods Medical expenditures were estimated for the U.S. population with and without diabetes in 2002 by sex, age, race/ethnicity, type of medical condition, and health care setting. Health care use and total health care expenditures attributable to diabetes were estimated using etiological fractions, calculated based on national health care survey data. The value of lost productivity attributable to diabetes was also estimated based on estimates of lost workdays, restricted activity days, prevalence of permanent disability, and mortality attributable to diabetes. RESULTS-Direct medical and indirect expenditures attributable to diabetes in 2002 were estimated at 132 billion US dollars. Direct medical expenditures alone totaled 91.8 billion US dollars and comprised 23.2 billion US dollars for diabetes care, 24.6 billion US dollars for chronic complications attributable to diabetes, and 44.1 billion US dollars for excess prevalence of general medical conditions. Inpatient days (43.9%), nursing home care (15.1%), and office visits (10.9%) constituted the major expenditure groups by service settings. In addition, 51.8% of direct medical expenditures were incurred by people >65 years old. Attributable indirect expenditures resulting from lost workdays, restricted activity days, mortality, and permanent disability due to diabetes totaled 39.8 billion US dollars. U.S. health expenditures for the health care components included in the study totaled 865 billion US dollars, of which 160 billion US dollars was incurred by people with diabetes. Per capita medical expenditures totaled 13243 US dollars for people with diabetes and 2560 US dollars for people without diabetes. When adjusting for differences in age, sex, and race/ethnicity between the population with and without diabetes, people with diabetes had medical expenditures that were approximately 2.4 times higher than expenditures that would be incurred by the same group in the absence of diabetes. Conclusions The estimated 132 billion US dollars cost likely underestimates the true burden of diabetes because it omits intangibles, such as pain and suffering, care provided by nonpaid caregivers, and several areas of health care spending where people with diabetes probably use services at higher rates than people without diabetes (e.g., dental care, optometry care, and the use of licensed dietitians). In addition, the cost estimate excludes undiagnosed cases of diabetes. Health care spending in 2002 for people with diabetes is more than double what spending would be without diabetes. Diabetes imposes a substantial cost burden to society and, in particular, to those individuals with diabetes and their families. Eliminating or reducing the health problems caused by diabetes through factors such as better access to preventive care, more widespread diagnosis, more intensive disease management, and the advent of new medical technologies could significantly improve the quality of life for people with diabetes and their families while at the same time potentially reducing national expenditures for health care services and increasing productivity in the U.S. economy.

Follow-up report on the diagnosis of diabetes mellitus.

Abstract: In 1997, an International Expert Committee was convened to reexamine the classification and diagnostic criteria of diabetes, which were based on the 1979 publication of the National Diabetes Data Group (1) and subsequent WHO study group (2). As a result of its deliberations, the Committee recommended several changes to the diagnostic criteria for diabetes and for lesser degrees of impaired glucose regulation (IFG/IGT) (3). The following were the major changes or issues addressed. 1) The use of a fasting plasma glucose (FPG) test for the diagnosis of diabetes was recommended, and the cut point separating diabetes from nondiabetes was lowered from FPG 140 mg/dl (7.8 mmol/l) to 126 mg/dl (7.0 mmol/l). (All glycemic values represent venous plasma.) This change was based on data that showed an increase in prevalence and incidence of diabetic retinopathy beginning at approximately a FPG of 126 mg/dl, as well as on the desire to reduce the discrepancy that existed in the number of cases detected by the FPG cut point of 140 mg/dl and the 2-h value in the OGTT (2-h plasma glucose [2-h PG]) of 200 mg/dl (11.1 mmol/l). 2) Normal FPG was defined as 110 mg/dl (6.1 mmol/l). 3) The use of HbA1c (A1C) as a diagnostic test for diabetes was not recommended. The primary reason for this decision was a lack of standardized methodology resulting in varying nondiabetic reference ranges among laboratories. 4) Although the OGTT (which consists of an FPG and 2-h PG value) was recognized as a valid way to diagnose diabetes, the use of the test for diagnostic purposes in clinical practice was discouraged for several reasons (e.g., inconvenience, less reproducibility, greater cost). The diagnostic category of impaired glucose tolerance (IGT) was retained to describe people whose FPG was 126 mg/dl but whose 2-h PG after a 75-g oral glucose challenge was 140–199 mg/dl. 5) The range of FPG levels between “normal” and that diagnostic for diabetes was named “impaired fasting glucose” (IFG). IFG identified people whose FPG ranged from 110 mg/dl (6.1 mmol/l) to 125 mg/dl (6.9 mmol/l). This construct was established so that there would be a fasting category analogous to IGT. The WHO consultation (4) also adopted most of the above conclusions. The two significant differences were that, whenever feasible, individuals with IFG should receive an OGTT to exclude the presence of diabetes, and the adoption of different criteria for the diagnosis of gestational diabetes. Since the 1997 Expert Committee report, many new data related to the diagnosis of diabetes have been published. First, many analyses of both old and new epidemiological data have examined the equivalence of the FPG and the 2-h PG to predict diabetes, and questions have been raised about the preference of the FPG test over the 2-h PG to diagnose diabetes (5– 7). Second, the IGT category has now been associated with cardiovascular disease (CVD) risk factors (8–10) and CVD events (10,11), whereas IFG is much less strongly associated with CVD events and CVD mortality (10,11). Third, the National Glycosylated Hemoglobin Standardization Program (NGSP) has now ensured that most laboratories in the U.S. perform the assays using standardized controls and report glycated hemoglobin results in a manner traceable to the assay used in the Diabetes Control and Complications Trial (DCCT) (12). These development s have improved as say performance and now allow caregivers and patients to compare reported results obtained among laboratories. Additional studies have suggested that the A1C may assist in diagnosing diabetes (13–17). Finally, data from major clinical trials that tested whether the progression from IGT to diabetes could be delayed or prevented by a treatment intervention have produced concordant results: intensive lifestyle modification (nutritional and exercise interventions) (18,19), metformin (19,20), and acarbose (20,21) were effective to variable degrees. In addition, a thiazolidinedione drug (troglitazone) reduced the incidence of diabetes in high-risk women with prior gestational diabetes (22). An inherent difficulty in the diagnosis of diabetes is the present lack of an identified unique qualitative biological marker that separates all people with diabetes from all nondiabetic individuals. The closest such characteristic for practical purposes is diabetic retinopathy, but this suffers from the obvious defect that in most diabetic patients, retinopathy usually becomes evident years after the recognized onset of diabetes. The lack of a suitable, unique marker of diabetes has led to reliance on the metabolic abnormality historically associated with the disease, i.e., hyperglycemia (as measured by the FPG or 2-h PG) as the most useful diagnostic test. The selection of diagnostic cut points for these tests rests on two ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Diabetic Autonomic Neuropathy

Abstract: Diabetic autonomic neuropathy (DAN) is a serious and common complication of diabetes. Despite its relationship to an increased risk of cardiovascular mortality and its association with multiple symptoms and impairments, the significance of DAN has not been fully appreciated. The reported prevalence of DAN varies widely depending on the cohort studied and the methods of assessment. In randomly selected cohorts of asymptomatic individuals with diabetes, 20% had abnormal cardiovascular autonomic function. DAN frequently coexists with other peripheral neuropathies and other diabetic complications, but DAN may be isolated, frequently preceding the detection of other complications. Major clinical manifestations of DAN include resting tachycardia, exercise intolerance, orthostatic hypotension, constipation, gastro- paresis, erectile dysfunction, sudomotor dysfunction, impaired neurovascular function, "brit- tle diabetes," and hypoglycemic autonomic failure. DAN may affect many organ systems throughout the body (e.g., gastrointestinal (GI), genitourinary, and cardiovascular). GI distur- bances (e.g., esophageal enteropathy, gastroparesis, constipation, diarrhea, and fecal inconti- nence) are common, and any section of the GI tract may be affected. Gastroparesis should be suspected in individuals with erratic glucose control. Upper-GI symptoms should lead to con- sideration of all possible causes, including autonomic dysfunction. Whereas a radiographic gastric emptying study can definitively establish the diagnosis of gastroparesis, a reasonable approach is to exclude autonomic dysfunction and other known causes of these upper-GI symptoms. Constipation is the most common lower-GI symptom but can alternate with episodes of diarrhea. Diagnostic approaches should rule out autonomic dysfunction and the well-known causes such as neoplasia. Occasionally, anorectal manometry and other specialized tests typically performed by the gastroenterologist may be helpful. DAN is also associated with genitourinary tract disturbances including bladder and/or sexual dysfunction. Evaluation of bladder dysfunc- tion should be performed for individuals with diabetes who have recurrent urinary tract infec- tions, pyelonephritis, incontinence, or a palpable bladder. Specialized assessment of bladder dysfunction will typically be performed by a urologist. In men, DAN may cause loss of penile erection and/or retrograde ejaculation. A complete workup for erectile dysfunction in men should include history (medical and sexual); psychological evaluation; hormone levels; mea- surement of nocturnal penile tumescence; tests to assess penile, pelvic, and spinal nerve func- tion; cardiovascular autonomic function tests; and measurement of penile and brachial blood pressure. Neurovascular dysfunction resulting from DAN contributes to a wide spectrum of clinical disorders including erectile dysfunction, loss of skin integrity, and abnormal vascular reflexes. Disruption of microvascular skin blood flow and sudomotor function may be among the earliest manifestations of DAN and lead to dry skin, loss of sweating, and the development of fissures and cracks that allow microorganisms to enter. These changes ultimately contribute to the development of ulcers, gangrene, and limb loss. Various aspects of neurovascular function can be evaluated with specialized tests, but generally these have not been well standardized and have limited clinical utility. Cardiovascular autonomic neuropathy (CAN) is the most studied and clinically important form of DAN. Meta-analyses of published data demonstrate that reduced cardiovascular autonomic function as measured by heart rate variability (HRV) is strongly (i.e., relative risk is doubled) associated with an in- creased risk of silent myocardial ischemia and mortality. The determination of the presence of CAN is usually based on a battery of auto- nomic function tests rather than just on one test. Proceedings from a consensus conference in 1992 recommended that three tests (R-R variation, Valsalva maneuver, and postural blood pressure testing) be used for longitudi- nal testing of the cardiovascular autonomic system. Other forms of autonomic neuropathy can be evaluated with specialized tests, but these are less standardized and less available than commonly used tests of cardiovascular autonomic function, which quantify loss of HRV. Interpretability of serial HRV testing re- quires accurate, precise, and reproducible procedures that use established physiological maneuvers. The battery of three recom- mended tests for assessing CAN is readily per- formed in the average clinic, hospital, or diagnostic center with the use of available technology. Measurement of HRV at the time of diagnosis of type 2 diabetes and within 5 years after diagnosis of type 1 diabetes (unless an individual has symptoms suggestive of au- tonomic dysfunction earlier) serves to estab- lish a baseline, with which 1-year interval tests can be compared. Regular HRV testing pro- vides early detection and thereby promotes timely diagnostic and therapeutic interven- tions. HRV testing may also facilitate differen- tial diagnosis and the attribution of symptoms (e.g., erectile dysfunction, dyspepsia, and diz- ziness) to autonomic dysfunction. Finally, knowledge of early autonomic dysfunction can encourage patient and physician to im- prove metabolic control and to use therapies such as ACE inhibitors and -blockers, proven to be effective for patients with CAN. Diabetes Care 26:1553-1579, 2003

The Finnish Diabetes Prevention Study (DPS) Lifestyle intervention and 3-year results on diet and physical activity

Abstract: OBJECTIVE —To describe the 1 ) lifestyle intervention used in the Finnish Diabetes Prevention Study, 2 ) short- and long-term changes in diet and exercise behavior, and 3 ) effect of the intervention on glucose and lipid metabolism. RESEARCH DESIGN AND METHODS —There were 522 middle-aged, overweight subjects with impaired glucose tolerance who were randomized to either a usual care control group or an intensive lifestyle intervention group. The control group received general dietary and exercise advice at baseline and had an annual physician’s examination. The subjects in the intervention group received additional individualized dietary counseling from a nutritionist. They were also offered circuit-type resistance training sessions and advised to increase overall physical activity. The intervention was the most intensive during the first year, followed by a maintenance period. The intervention goals were to reduce body weight, reduce dietary and saturated fat, and increase physical activity and dietary fiber. RESULTS —The intervention group showed significantly greater improvement in each intervention goal. After 1 and 3 years, weight reductions were 4.5 and 3.5 kg in the intervention group and 1.0 and 0.9 kg in the control group, respectively. Measures of glycemia and lipemia improved more in the intervention group. CONCLUSIONS —The intensive lifestyle intervention produced long-term beneficial changes in diet, physical activity, and clinical and biochemical parameters and reduced diabetes risk. This type of intervention is a feasible option to prevent type 2 diabetes and should be implemented in the primary health care system.

Inflammation and Insulin Resistance

Abstract: This Is the second of two articles describing a symposium on the relationship between inflammation and insulin resistance that was held in Niagra Falls, NY, 20–21 September 2002. Antonio Ceriello (Udine, Italy) discussed the role of glucose intake and postprandial hyperglycemia in the development of diabetes complications, as well as the relationship of hyperglycemia to oxidative stress. The DECODE (Diabetes Epidemiology: Collaborative analysis Of Diagnostic criteria in Europe) study showed high 2-h postload glucose to be associated with increased mortality independent of fasting glucose (1), and the Pacific and Indian Ocean Study showed isolated 2-h hyperglycemia to double the risk of mortality (2). The Funagata Diabetes Study showed that impaired glucose tolerance (IGT) but not impaired fasting glucose was a risk factor for cardiovascular disease (CVD) (3). There is evidence that lowering postprandial glucose improves outcome. Post hoc analysis of the STOP-type 2 diabetes study showed that myocardial infarction and hypertension decrease with use of the prandial glucose-lowering agent acarbose (4). In the Kumamoto study, postprandial hyperglycemia strongly predicted retinopathy and nephropathy (5). Endothelial dysfunction (ED) is a potential mediator of the effect of prandial glycemia, with altered vasodilation and procoagulant abnormalities. ED can be induced by hyperglycemia following a 75-g oral glucose load in persons with normal or IGT or with diabetes, with reduction of flow-mediated brachial artery dilation proportional to the degree of hyperglycemia (6). In a study of 225 persons with hypertension followed for 32 months, forearm ED was a marker of future CVD events (7), with a 4.5-year follow-up of 281 persons showing both ED and measures of oxidative stress to predict CVD events (8). Acute hyperglycemia may suppress vasodilation, which may involve oxidant stress, as it is reversed with antioxidant or l-arginine treatment (9). Glucose increases endothelial cell free radical production leading …

The diabetes risk score: a practical tool to predict type 2 diabetes risk.

Abstract: OBJECTIVE —Interventions to prevent type 2 diabetes should be directed toward individuals at increased risk for the disease. To identify such individuals without laboratory tests, we developed the Diabetes Risk Score. RESEARCH DESIGN AND METHODS —A random population sample of 35- to 64-year-old men and women with no antidiabetic drug treatment at baseline were followed for 10 years. New cases of drug-treated type 2 diabetes were ascertained from the National Drug Registry. Multivariate logistic regression model coefficients were used to assign each variable category a score. The Diabetes Risk Score was composed as the sum of these individual scores. The validity of the score was tested in an independent population survey performed in 1992 with prospective follow-up for 5 years. RESULTS —Age, BMI, waist circumference, history of antihypertensive drug treatment and high blood glucose, physical activity, and daily consumption of fruits, berries, or vegetables were selected as categorical variables. Complete baseline risk data were found in 4,435 subjects with 182 incident cases of diabetes. The Diabetes Risk Score value varied from 0 to 20. To predict drug-treated diabetes, the score value ≥9 had sensitivity of 0.78 and 0.81, specificity of 0.77 and 0.76, and positive predictive value of 0.13 and 0.05 in the 1987 and 1992 cohorts, respectively. CONCLUSIONS —The Diabetes Risk Score is a simple, fast, inexpensive, noninvasive, and reliable tool to identify individuals at high risk for type 2 diabetes.

The Treat-to-Target Trial: Randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients

Abstract: OBJECTIVE —To compare the abilities and associated hypoglycemia risks of insulin glargine and human NPH insulin added to oral therapy of type 2 diabetes to achieve 7% HbA 1c . RESEARCH DESIGN AND METHODS —In a randomized, open-label, parallel, 24-week multicenter trial, 756 overweight men and women with inadequate glycemic control (HbA 1c >7.5%) on one or two oral agents continued prestudy oral agents and received bedtime glargine or NPH once daily, titrated using a simple algorithm seeking a target fasting plasma glucose (FPG) ≤100 mg/dl (5.5 mmol/l). Outcome measures were FPG, HbA 1c , hypoglycemia, and percentage of patients reaching HbA 1c ≤7% without documented nocturnal hypoglycemia. RESULTS —Mean FPG at end point was similar with glargine and NPH (117 vs. 120 mg/dl [6.5 vs. 6.7 mmol/l]), as was HbA 1c (6.96 vs. 6.97%). A majority of patients (∼60%) attained HbA 1c ≤7% with each insulin type. However, nearly 25% more patients attained this without documented nocturnal hypoglycemia (≤72 mg/dl [4.0 mmol/l]) with glargine (33.2 vs. 26.7%, P CONCLUSIONS —Systematically titrating bedtime basal insulin added to oral therapy can safely achieve 7% HbA 1c in a majority of overweight patients with type 2 diabetes with HbA 1c between 7.5 and 10.0% on oral agents alone. In doing this, glargine causes significantly less nocturnal hypoglycemia than NPH, thus reducing a leading barrier to initiating insulin. This simple regimen may facilitate earlier and effective insulin use in routine medical practice, improving achievement of recommended standards of diabetes care.

Contributions of fasting and postprandial plasma glucose increments to the overall diurnal hyperglycemia of type 2 diabetic patients: variations with increasing levels of HbA(1c).

Abstract: OBJECTIVE —The exact contributions of postprandial and fasting glucose increments to overall hyperglycemia remain controversial. The discrepancies between the data published previously might be caused by the interference of several factors. To test the effect of overall glycemic control itself, we analyzed the diurnal glycemic profiles of type 2 diabetic patients investigated at different levels of HbA 1c . RESEARCH DESIGN AND METHODS —In 290 non–insulin- and non–acarbose-using patients with type 2 diabetes, plasma glucose (PG) concentrations were determined at fasting (8:00 a.m.) and during postprandial and postabsorptive periods (at 11:00 a.m., 2:00 p.m., and 5:00 p.m.). The areas under the curve above fasting PG concentrations (AUC 1 ) and >6.1 mmol/l (AUC 2 ) were calculated for further evaluation of the relative contributions of postprandial (AUC 1 /AUC 2 , %) and fasting [(AUC 2 − AUC 1 )/AUC 2 , %] PG increments to the overall diurnal hyperglycemia. The data were compared over quintiles of HbA 1c . RESULTS —The relative contribution of postprandial glucose decreased progressively from the lowest (69.7%) to the highest quintile of HbA 1c (30.5%, P 1c : 30.3% in the lowest vs. 69.5% in the highest quintile ( P CONCLUSIONS —The relative contribution of postprandial glucose excursions is predominant in fairly controlled patients, whereas the contribution of fasting hyperglycemia increases gradually with diabetes worsening. These results could therefore provide a unifying explanation for the discrepancies as observed in previous studies.

National Standards for Diabetes Self-Management Education

Abstract: Diabetes self-management education (DSME) is a critical element of care for all people with diabetes and is necessary in order to improve patient outcomes. The National Standards for DSME are designed to define quality diabetes self-management education and to assist diabetes educators in a variety of settings to provide evidence-based education. Because of the dynamic nature of health care and diabetes-related research, these Standards are reviewed and revised approximately every 5 years by key organizations and federal agencies within the diabetes education community. A Task Force was jointly convened by the American Association of Diabetes Educators and the American Diabetes Association in the summer of 2006. Additional organizations that were represented included the American Dietetic Association, the Veteran's Health Administration, the Centers for Disease Control and Prevention, the Indian Health Service, and the American Pharmaceutical Association. Members of the Task Force included a person with diabetes; several health services researchers/behaviorists, registered nurses, and registered dietitians; and a pharmacist. The Task Force was charged with reviewing the current DSME standards for their appropriateness, relevance, and scientific basis. The Standards were then reviewed and revised based on the available evidence and expert consensus. The committee convened on 31 March 2006 and 9 September 2006, and the Standards were approved 25 March 2007. Diabetes self-management education (DSME) is the ongoing process of facilitating the knowledge, skill, and ability necessary for diabetes self-care. This process incorporates the needs, goals, and life experiences of the person with diabetes and is guided by evidence-based standards. The overall objectives of DSME are to support informed decision-making, self-care behaviors, problem-solving and active collaboration with the health care team and to improve clinical outcomes, health status, and quality of life. Before the review of the individual Standards, the Task Force identified overriding principles based on existing evidence that would …

Adiponectin: More Than Just Another Fat Cell Hormone?

Abstract: Recent research has shown that adipose tissue is not simply an inert storage depot for lipids but is also an important endocrine organ that plays a key role in the integration of endocrine, metabolic, and inflammatory signals for the control of energy homeostasis. The adipocyte has been shown to secrete a variety of bioactive proteins into the circulation. These secretory proteins, which have been collectively named adipocytokines (1), include leptin (2), tumor necrosis factor (TNF)-α (3), plasminogen-activator inhibitor type 1 (PAI-1) (4), adipsin (5), resistin (6), and adiponectin (7). Adiponectin, the gene product of the adipose most abundant gene transcript 1 (apM1) (7), is a novel and important member of the adipocytokine family. Adiponectin cDNA was first isolated by large-scale random sequencing of the human adipose tissue cDNA library (7). It is a collagen-like protein that is exclusively synthesized in white adipose tissue, is induced during adipocyte differentiation, and circulates at relatively high (microgram/milliliter) concentrations in the serum. Both murine and human forms of adiponectin have been isolated independently by several groups, and various descriptive names have been given to the same compound by different investigators: adipocyte complement-related protein of 30 kilodalton (Acrp30) (8), Adipo Q (9), and gelatin binding protein of 28 kilodalton (GBP28) (10). The former two are murine analogs and the latter the human counterpart. Throughout this review, we will be referring to the protein by its most commonly used name, adiponectin. Adiponectin has been postulated to play an important role in the modulation of glucose and lipid metabolism in insulin-sensitive tissues in both humans and animals. Decreased circulating adiponectin levels have been demonstrated in genetic and diet-induced murine models of obesity (11), as well as in diet-induced forms of human obesity (12). Low adiponectin levels have also been strongly implicated in the development of insulin resistance …

Cinnamon Improves Glucose and Lipids of People with Type 2 Diabetes

Abstract: OBJECTIVE — The objective of this study was to determine whether cinnamon improves blood glucose, triglyceride, total cholesterol, HDL cholesterol, and LDL cholesterol levels in people with type 2 diabetes. RESEARCH DESIGN AND METHODS — A total of 60 people with type 2 diabetes, 30 men and 30 women aged 52.2 6.32 years, were divided randomly into six groups. Groups 1, 2, and 3 consumed 1, 3, or 6 g of cinnamon daily, respectively, and groups 4, 5, and 6 were given placebo capsules corresponding to the number of capsules consumed for the three levels of cinnamon. The cinnamon was consumed for 40 days followed by a 20-day washout period. RESULTS — After 40 days, all three levels of cinnamon reduced the mean fasting serum glucose (18 –29%), triglyceride (23–30%), LDL cholesterol (7–27%), and total cholesterol (12– 26%) levels; no significant changes were noted in the placebo groups. Changes in HDL cholesterol were not significant. CONCLUSIONS — The results of this study demonstrate that intake of 1, 3, o r6go f cinnamon per day reduces serum glucose, triglyceride, LDL cholesterol, and total cholesterol in people with type 2 diabetes and suggest that the inclusion of cinnamon in the diet of people with type 2 diabetes will reduce risk factors associated with diabetes and cardiovascular diseases. Diabetes Care 26:3215–3218, 2003

Low–Glycemic Index Diets in the Management of Diabetes A meta-analysis of randomized controlled trials

Abstract: OBJECTIVE —The use of diets with low glycemic index (GI) in the management of diabetes is controversial, with contrasting recommendations around the world. We performed a meta-analysis of randomized controlled trials to determine whether low-GI diets, compared with conventional or high-GI diets, improved overall glycemic control in individuals with diabetes, as assessed by reduced HbA 1c or fructosamine levels. RESEARCH DESIGN AND METHODS —Literature searches identified 14 studies, comprising 356 subjects, that met strict inclusion criteria. All were randomized crossover or parallel experimental design of 12 days’ to 12 months’ duration (mean 10 weeks) with modification of at least two meals per day. Only 10 studies documented differences in postprandial glycemia on the two types of diet. RESULTS —Low-GI diets reduced HbA 1c by 0.43% points (CI 0.72–0.13) over and above that produced by high-GI diets. Taking both HbA 1c and fructosamine data together and adjusting for baseline differences, glycated proteins were reduced 7.4% (8.8–6.0) more on the low-GI diet than on the high-GI diet. This result was stable and changed little if the data were unadjusted for baseline levels or excluded studies of short duration. Systematically taking out each study from the meta-analysis did not change the CIs. CONCLUSIONS —Choosing low-GI foods in place of conventional or high-GI foods has a small but clinically useful effect on medium-term glycemic control in patients with diabetes. The incremental benefit is similar to that offered by pharmacological agents that also target postprandial hyperglycemia.

A prospective study of self-reported sleep duration and incident diabetes in women.

Abstract: Short-term sleep restriction results in impaired glucose tolerance. To test whether habitually short sleep duration increases the risk of developing diabetes, we studied a cohort of 70,026 women enrolled in the Nurses Health Study, without diabetes at baseline, and who responded to a question about daily sleep duration in 1986. Subjects were followed until 1996 for the diagnosis of diabetes (1,969 cases). Long and short sleep durations were associated with an increased risk of diabetes diagnosis. The relative risks (RRs) for short (slept ≤5 h per day) and long (slept ≥9 h per day) sleepers were 1.57 (95% CI 1.28–1.92) and 1.47 (1.19–1.80), respectively. After adjustment for BMI and a variety of confounders, the RR was not significantly increased for short sleepers (1.18 [0.96–1.44]) but remained modestly increased for long sleepers (1.29 [1.05–1.59]). We then performed a similar analysis using only symptomatic cases ( n = 1,187). Adjusted RRs for symptomatic diabetes were modestly elevated in both short (1.34 [1.04–1.72]) and long (1.35 [1.04–1.75]) sleepers. Our data suggest that the association between a reduced self-reported sleep duration and diabetes diagnosis could be due to confounding by BMI, or sleep restriction may mediate its effects on diabetes through weight gain. Sleep restriction may be an independent risk factor for developing symptomatic diabetes.

Systematic Review of Herbs and Dietary Supplements for Glycemic Control in Diabetes

Abstract: OBJECTIVE —To conduct a systematic review of the published literature on the efficacy and safety of herbal therapies and vitamin/mineral supplements for glucose control in patients with diabetes. RESEARCH DESIGN AND METHODS —We conducted an electronic literature search of MEDLINE, OLDMEDLINE, Cochrane Library Database, and HealthSTAR, from database inception to May 2002, in addition to performing hand searches and consulting with experts in the field. Available clinical studies published in the English language that used human participants and examined glycemic control were included. Data were extracted in a standardized manner, and two independent investigators assessed methodological quality of randomized controlled trials using the Jadad scale. RESULTS —A total of 108 trials examining 36 herbs (single or in combination) and 9 vitamin/mineral supplements, involving 4,565 patients with diabetes or impaired glucose tolerance, met the inclusion criteria and were analyzed. There were 58 controlled clinical trials involving individuals with diabetes or impaired glucose tolerance (42 randomized and 16 nonrandomized trials). Most studies involved patients with type 2 diabetes. Heterogeneity and the small number of studies per supplement precluded formal meta-analyses. Of these 58 trials, the direction of the evidence for improved glucose control was positive in 76% (44 of 58). Very few adverse effects were reported. CONCLUSIONS —There is still insufficient evidence to draw definitive conclusions about the efficacy of individual herbs and supplements for diabetes; however, they appear to be generally safe. The available data suggest that several supplements may warrant further study. The best evidence for efficacy from adequately designed randomized controlled trials (RCTs) is available for Coccinia indica and American ginseng. Chromium has been the most widely studied supplement. Other supplements with positive preliminary results include Gymnema sylvestre , Aloe vera , vanadium, Momordica charantia , and nopal.

The Metabolic Syndrome as Predictor of Type 2 Diabetes: The San Antonio Heart Study

Abstract: OBJECTIVE —The oral glucose tolerance test identifies high-risk subjects for diabetes, but it is costly and inconvenient. To find better predictors of type 2 diabetes, we evaluated two different definitions of the metabolic syndrome because insulin resistance, which is commonly associated with this clustering of metabolic factors, frequently precedes the onset of type 2 diabetes. RESEARCH DESIGN AND METHODS —We compared the ability of the National Cholesterol Education Program (NCEP) definition, a modified version of the 1999 World Health Organization (WHO) definition that excludes the 2-h glucose requirement, and impaired glucose tolerance (IGT) to predict incident type 2 diabetes. In the San Antonio Heart Study, 1,734 participants completed a 7- to 8-year follow-up examination. RESULTS —IGT and the NCEP definition had higher sensitivity than the modified WHO definition (51.9, 52.8, and 42.8%, respectively). IGT had a higher positive predictive value than the NCEP and modified WHO definitions (43.0, 30.8, and 30.4%, respectively). The combination of the IGT and NCEP definitions increased the sensitivity to 70.8% with an acceptable positive predictive value of 29.7%. Risk for incidence of type 2 diabetes using the NCEP definition was independent of other risk factors, including IGT and fasting insulin (odds ratio 3.30, 95% CI 2.27-4.80). The NCEP definition performed better with fasting glucose ≥5.4 mmol/l (sensitivity 62.0% and positive predictive value 30.9%). CONCLUSIONS —The metabolic syndrome predicts diabetes independently of other factors. However, the NCEP definition performs better than the modified 1999 WHO definition. Lowering the fasting glucose cutoff to 5.4 mmol/l improves the prediction of diabetes by the metabolic syndrome.

Diabetic Retinopathy and Diabetic Macular Edema: Pathophysiology, screening, and novel therapies

Abstract: Diabetic retinopathy (DR) and diabetic macular edema (DME) are leading causes of blindness in the working-age population of most developed countries. The increasing number of individuals with diabetes worldwide suggests that DR and DME will continue to be major contributors to vision loss and associated functional impairment for years to come. Early detection of retinopathy in individuals with diabetes is critical in preventing visual loss, but current methods of screening fail to identify a sizable number of high-risk patients. The control of diabetes-associated metabolic abnormalities (i.e., hyperglycemia, hyperlipidemia, and hypertension) is also important in preserving visual function because these conditions have been identified as risk factors for both the development and progression of DR/DME. The currently available interventions for DR/DME, laser photocoagulation and vitrectomy, only target advanced stages of disease. Several biochemical mechanisms, including protein kinase C-beta activation, increased vascular endothelial growth factor production, oxidative stress, and accumulation of intracellular sorbitol and advanced glycosylation end products, may contribute to the vascular disruptions that characterize DR/DME. The inhibition of these pathways holds the promise of intervention for DR at earlier non-sight-threatening stages. To implement new therapies effectively, more individuals will need to be screened for DR/DME at earlier stages-a process requiring both improved technology and interdisciplinary cooperation among physicians caring for patients with diabetes.

Quantifying the Risk of Infectious Diseases for People With Diabetes

Abstract: OBJECTIVE —In vitro evidence shows that immune function is compromised in people with diabetes. Although certain rare infections are more common and infection-related mortality is higher, the risk of acquiring an infectious disease for diabetic patients has never been quantified. RESEARCH DESIGN AND METHODS —A retrospective cohort study using administrative data compared all people with diabetes in Ontario, Canada, on 1 April 1999 to matched nondiabetic people ( n = 513,749 in each group). The risk ratios of having an infectious disease and of death attributable to infectious disease between those with and without diabetes were calculated. Secondary analysis individually examined common infectious diseases. The study was repeated using a second pair of cohorts defined in 1996 to confirm stability of the estimates. RESULTS —Nearly half of all people with diabetes had at least one hospitalization or physician claim for an infectious disease in each cohort year. The risk ratio for diabetic versus nondiabetic people was 1.21 (99% CI 1.20–1.22) in both cohort years. The risk ratio for infectious disease-related hospitalization was up to 2.17 (99% CI 2.10–2.23). The risk ratio for death attributable to infection was up to 1.92 (1.79–2.05). Many individual infections were more common in people with diabetes, especially serious bacterial infections. CONCLUSIONS —Diabetes confers an increased risk of developing and dying from an infectious disease, corroborating both in vitro evidence and commonly held clinical belief. In addition to microvascular and macrovascular sequelae, clinicians should consider infection a complication of diabetes.

New insights on oxidative stress and diabetic complications may lead to a "causal" antioxidant therapy

Abstract: Evidence implicates hyperglycemia-derived oxygen free radicals as mediators of diabetic complications. However, intervention studies with classic antioxidants, such as vitamin E, failed to demonstrate any beneficial effect. Recent studies demonstrate that a single hyperglycemia-induced process of overproduction of superoxide by the mitochondrial electron-transport chain seems to be the first and key event in the activation of all other pathways involved in the pathogenesis of diabetic complications. These include increased polyol pathway flux, increased advanced glycosylation end product formation, activation of protein kinase C, and increased hexosamine pathway flux. Superoxide overproduction is accompanied by increased nitric oxide generation, due to an endothelial NOS and inducible NOS uncoupled state, a phenomenon favoring the formation of the strong oxidant peroxynitrite, which in turn damages DNA. DNA damage is an obligatory stimulus for the activation of the nuclear enzyme poly(ADP-ribose) polymerase. Poly(ADP-ribose) polymerase activation in turn depletes the intracellular concentration of its substrate NAD+, slowing the rate of glycolysis, electron transport, and ATP formation, and produces an ADP-ribosylation of the GAPDH. These processes result in acute endothelial dysfunction in diabetic blood vessels that, convincingly, also contributes to the development of diabetic complications. These new findings may explain why classic antioxidants, such as vitamin E, which work by scavenging already-formed toxic oxidation products, have failed to show beneficial effects on diabetic complications and may suggest new and attractive “causal” antioxidant therapy. New low–molecular mass compounds that act as SOD or catalase mimetics or l-propionyl-carnitine and lipoic acid, which work as intracellular superoxide scavengers, improving mitochondrial function and reducing DNA damage, may be good candidates for such a strategy, and preliminary studies support this hypothesis. This “causal” therapy would also be associated with other promising tools such as LY 333531, PJ34, and FP15, which block the protein kinase β isoform, poly(ADP-ribose) polymerase, and peroxynitrite, respectively. While waiting for these focused tools, we may have other options: thiazolinediones, statins, ACE inhibitors, and angiotensin 1 inhibitors can reduce intracellular oxidative stress generation, and it has been suggested that many of their beneficial effects, even in diabetic patients, are due to this property.

A Comparison of the Prevalence of the Metabolic Syndrome Using Two Proposed Definitions

Abstract: OBJECTIVE—To compare the prevalence of the metabolic syndrome using two definitions: one proposed by the Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III [ATP III]) and one by the World Health Organization (WHO). RESEARCH DESIGN AND METHODS—We used data from a nationally representative sample of the noninstitutionalized civilian population of the U.S. from the Third National Health and Nutrition Examination Survey, a cross-sectional health examination survey (1988–1994). RESULTS—Among 8,608 participants aged ≥20 years, the age-adjusted prevalence was 23.9% using the ATP III definition and 25.1% using the WHO definition. Among all participants, 86.2% were classified as either having or not having the metabolic syndrome under both definitions. Estimates differed substantially for some subgroups, however. For example, in African-American men, the WHO estimate was 24.9%, compared with the ATP III estimate of 16.5%. CONCLUSIONS—A universally accepted definition of the metabolic syndrome is needed.

β-Cell Function and the Development of Diabetes-Related Complications in the Diabetes Control and Complications Trial

Abstract: In patients with type 1 diabetes, measurement of connecting peptide (C-peptide), cosecreted with insulin from the islets of Langerhans, permits estimation of remaining β-cell secretion of insulin. In this retrospective analysis to distinguish the incremental benefits of residual β-cell activity in type 1 diabetes, stimulated (90 min following ingestion of a mixed meal) C-peptide levels at entry in the Diabetes Control and Complications Trial (DCCT) were related to measures of diabetic retinopathy and nephropathy and to incidents of severe hypoglycemia. Based on the analytical sensitivity of the assay (0.03 nmol/l) and study entry criteria, the DCCT subjects were divided into four groups of stimulated C-peptide responses: ≤0.03, 0.04–0.20, 0.21–0.50 nmol/l at entry, and 0.21–0.50 nmol/l at entry and at least 1 year later (sustained C-peptide secretion). Uniformly in the intensive and partially in the conventional DCCT treatment groups, any C-peptide secretion, but especially at higher and sustained levels of stimulated C-peptide, was associated with reduced incidences of retinopathy (both a single three-step change and a repeated three-step change on the Early Treatment of Diabetic Retinopathy Study [ETDRS] scale at the next 6 month visit) and nephropathy (both albuminuria >40 mg/24 h once and repeated at the next annual visit). There were also differences in severe hypoglycemia across C-peptide levels in both treatment groups. In the intensively treated cohort there were essentially identical prevalences of severe hypoglycemia (∼65% of participants) in the first three groups; however, those subjects with mixed-meal stimulated C-peptide level >0.20 nmol/l for at least baseline and the first annual visit in the DCCT experienced a reduced prevalence of ∼30%. Therefore, even modest levels of β-cell activity at entry in the DCCT were associated with reduced incidences of retinopathy and nephropathy. Also, continuing C-peptide (insulin) secretion is important in avoiding hypoglycemia (the major complication of intensive diabetic therapy).

The Efficacy and Safety of Dermagraft in Improving the Healing of Chronic Diabetic Foot Ulcers: Results of a prospective randomized trial

Abstract: OBJECTIVE —To determine if a human fibroblast–derived dermal substitute could promote the healing of diabetic foot ulcers. RESEARCH DESIGN AND METHODS —A randomized, controlled, multicenter study was undertaken at 35 centers throughout the U.S. and enrolled 314 patients to evaluate complete wound closure by 12 weeks. Patients were randomized to either the Dermagraft treatment group or control (conventional therapy). Except for the application of Dermagraft, treatment of study ulcers was identical for patients in both groups. All patients received pressure-reducing footwear and were allowed to be ambulatory during the study. RESULTS —The results demonstrated that patients with chronic diabetic foot ulcers of >6 weeks duration experienced a significant clinical benefit when treated with Dermagraft versus patients treated with conventional therapy alone. With regard to complete wound closure by week 12, 30.0% (39 of 130) of Dermagraft patients healed compared with 18.3% (21 of 115) of control patients ( P = 0.023). The overall incidence of adverse events was similar for both the Dermagraft and control groups, but the Dermagraft group experienced significantly fewer ulcer-related adverse events. CONCLUSIONS —The data from this study show that Dermagraft is a safe and effective treatment for chronic diabetic foot ulcers.

The Association Between Cardiovascular Autonomic Neuropathy and Mortality in Individuals With Diabetes: A meta-analysis

Abstract: OBJECTIVE —To examine by meta-analysis the relationship between cardiovascular autonomic neuropathy (CAN) and risk of mortality in individuals with diabetes. RESEARCH DESIGN AND METHODS —We searched Medline for English-language articles published from 1966 to 2001. Fifteen studies having a baseline assessment of cardiovascular autonomic function and mortality follow-up were identified. The analyses were stratified according to whether a single abnormality or two or more measures of cardiovascular autonomic function were used to define CAN. A global measure of association (i.e., relative risk) was generated for each group by pooling estimates across the studies using the Mantel-Haenszel procedure. RESULTS —CAN was significantly associated with subsequent mortality in both groups, although the magnitude of the association was stronger for those studies for which two or more measures were used to define CAN. The pooled relative risk for studies that defined CAN with the presence of two or more abnormalities was 3.45 (95% CI 2.66–4.47; P P = 0.03) for studies that used one measure. CONCLUSIONS —These results support an association between CAN and increased risk of mortality. The stronger association observed in studies defining CAN by the presence of two or more abnormalities may be due to more severe autonomic dysfunction in these subjects or a higher frequency of other comorbid complications that contributed to their higher mortality risk. Future studies should evaluate whether early identification of subjects with CAN can lead to a reduction in mortality.

Enhancing Incretin Action for the Treatment of Type 2 Diabetes

Abstract: OBJECTIVE —To examine the mechanisms of action, therapeutic potential, and challenges inherent in the use of incretin peptides and dipeptidyl peptidase-IV (DPP-IV) inhibitors for the treatment of type 2 diabetes. RESEARCH DESIGN AND METHODS —The scientific literature describing the biological importance of incretin peptides and DPP-IV inhibitors in the control of glucose homeostasis has been reviewed, with an emphasis on mechanisms of action, experimental diabetes, human physiological experiments, and short-term clinical studies in normal and diabetic human subjects. RESULTS —Glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP) exert important effects on β-cells to stimulate glucose-dependent insulin secretion. Both peptides also regulate β-cell proliferation and cytoprotection. GLP-1, but not GIP, inhibits gastric emptying, glucagon secretion, and food intake. The glucose-lowering actions of GLP-1, but not GIP, are preserved in subjects with type 2 diabetes. However, native GLP-1 is rapidly degraded by DPP-IV after parenteral administration; hence, degradation-resistant, long-acting GLP-1 receptor (GLP-1R) agonists are preferable agents for the chronic treatment of human diabetes. Alternatively, inhibition of DPP-IV–mediated incretin degradation represents a complementary therapeutic approach, as orally available DPP-IV inhibitors have been shown to lower glucose in experimental diabetic models and human subjects with type 2 diabetes. CONCLUSIONS —GLP-1R agonists and DPP-IV inhibitors have shown promising results in clinical trials for the treatment of type 2 diabetes. The need for daily injections of potentially immunogenic GLP-1–derived peptides and the potential for unanticipated side effects with chronic use of DPP-IV inhibitors will require ongoing scrutiny of the risk-benefit ratio for these new therapies as they are evaluated in the clinic.

The Health Care Costs of Diabetic Peripheral Neuropathy in the U.S.

Abstract: OBJECTIVE —Peripheral neuropathy is common among people with diabetes and can result in foot ulceration and amputation. The aim of this study was to quantify the annual medical costs of peripheral neuropathy and its complications among people with type 1 and type 2 diabetes in the U.S. RESEARCH DESIGN AND METHODS —A cost-of-illness model was used to estimate the numbers of diabetic individuals in the U.S. who have diabetic peripheral neuropathy (DPN) and/or neuropathic foot ulcers (both those with no deep infection and those accompanied by cellulitis or osteomyelitis) at a given point in time, and/or a toe, foot, or leg amputation during a year. Prevalence and incidence rates were estimated from published studies and applied to the general U.S. population. All costs were estimated in 2001 U.S. dollars. In a sensitivity analysis, we varied the rates of complications to assess the robustness of the cost estimates. RESULTS —The annual costs of DPN and its complications in the U.S. were $0.8 billion (type 1 diabetes), $10.1 billion (type 2 diabetes), and $10.9 billion (total). After allowing for uncertainty in the point estimates of complication rates, the range of costs were between $0.3 and $1.0 billion (type 1 diabetes), $4.3b and $12.7 billion (type 2 diabetes), and $4.6 and $13.7 billion (type 1 and type 2 diabetes). CONCLUSIONS —The total annual cost of DPN and its complications in the U.S. was estimated to be between $4.6 and $13.7 billion. Up to 27% of the direct medical cost of diabetes may be attributed to DPN.

The prevention or delay of type 2 diabetes.

Abstract: Diabetes is one of the most costly and burdensome chronic diseases of our time and is a condition that is increasing in epidemic proportions in the U.S. and throughout the world.1 The complications resulting from the disease are a significant cause of morbidity and mortality and are associated with the damage or failure of various organs such as the eyes, kidneys, and nerves. Individuals with type 2 diabetes are also at a significantly higher risk for coronary heart disease, peripheral vascular disease, and stroke, and they have a greater likelihood of having hypertension, dyslipidemia, and obesity.2–6 There is also growing evidence that at glucose levels above normal but below the threshold diagnostic for diabetes, there is a substantially increased risk of cardiovascular disease (CVD) and death.5,7–10 In these individuals, CVD risk factors are also more prevalent,5–7,9,11–14 which further increases the risk but is not sufficient to totally explain it. In contrast to the clear benefit of glucose lowering to prevent or retard the progression of microvascular complications associated with diabetes,15–18,21 it is less clear whether the high rate of CVD in people with impaired glucose homeostasis, i.e., those with impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or diabetes, is caused by elevated blood glucose levels or will respond to treatments that lower blood glucose. Epidemiological studies have shown a clear relationship,19,20 whereas intervention trials in people with diabetes suggest, but have not demonstrated, a clear benefit of glycemic control.15,16,21,22 Additionally, there are no studies that have investigated a benefit of glucose lowering on macrovascular disease in subjects with only IFG or IGT but not diabetes. Although the treatment of diabetes has become increasingly sophisticated, with over a dozen pharmacological agents available to lower blood glucose, a multitude of ancillary supplies and equipment available, and a clear recognition by health care professionals and patients that diabetes is a serious disease, the normalization of blood glucose for any appreciable period of time is seldom achieved.23 In addition, in well-controlled so-called “intensively” treated patients, serious complications still occur,15–18,21 and the economic and personal burden of diabetes remains. Furthermore, microvascular disease is already present in many individuals with undiagnosed or newly diagnosed type 2 diabetes.11,24–28 Given these facts, it is not surprising that studies have been initiated in the last decade to determine the feasibility and benefit of various strategies to prevent or delay the onset of type 2 diabetes. Two early reports29,30 suggested that changes in lifestyle can prevent diabetes, but weaknesses in study design limited their general relevance. Recently, however, four welldesigned randomized controlled trials have been reported.31–35 In the Finnish study,31 522 middleaged (mean age 55 years) obese (mean BMI 31 kg/m2) subjects with IGT were randomized to receive either brief diet and exercise counseling (control group) or intensive individualized instruction on weight reduction, food intake, and guidance on increasing physical activity (intervention group). After an average followup of 3.2 years, there was a 58% relative reduction in the incidence of diabetes in the intervention group compared with the control subjects. A strong correlation was also seen between the ability to stop the progression to diabetes and the degree to which subjects were able to achieve one or more of the following: lose weight (goal of 5.0% weight reduction), reduce fat intake (goal of <30% of calories), reduce saturated fat intake (goal of <10% of calories), increase fiber intake (goal of ≥15 g/1,000 kcal), and exercise (goal of >150 min/week). No untoward effects of the lifestyle interventions were observed. In the Diabetes Prevention Program (DPP),32–34 the 3,234 enrolled subjects were slightly younger (mean age 51 years) and more obese (mean BMI 34 kg/m2) but had nearly identical glucose intolerance compared with subjects in the Finnish study. About 45% of the participants were from minority groups (e.g, African-American, Hispanic), and 20% were ≥60 years of age. Subjects were randomized to one of three intervention groups, which included the intensive nutrition and exercise counseling (“lifestyle”) group or either of two masked medication treatment groups: the biguanide metformin group or the placebo group. The latter interventions were combined with standard diet and exercise recommendations. After an average follow-up of 2.8 years (range 1.8–4.6 years), a 58% relative reduction in the progression to diabetes was observed in the lifestyle group (absolute incidence 4.8%), and a 31% relative reduction in the progression of diabetes was observed in the metformin group (absolute incidence 7.8%) compared Position Statement

Association between regional adipose tissue distribution and both type 2 diabetes and impaired glucose tolerance in elderly men and women.

Abstract: OBJECTIVE —We examined whether regional adipose tissue distribution, specifically that of skeletal muscle fat and visceral abdominal fat aggregation, is characteristic of elderly individuals with hyperinsulinemia, type 2 diabetes, and impaired glucose tolerance (IGT) RESEARCH DESIGN AND METHODS —A total of 2,964 elderly men and women (mean age 736 years) were recruited for cross-sectional comparisons of diabetes or glucose tolerance, generalized obesity with dual-energy X-ray absorptiometry, and regional body fat distribution with computed tomography RESULTS —Approximately one-third of men with type 2 diabetes and less than half of women with type 2 diabetes were obese (BMI ≥30 kg/m 2 ) Despite similar amounts of subcutaneous thigh fat, intermuscular fat was higher in subjects with type 2 diabetes and IGT than in subjects with normal glucose tolerance (NGT) (112 ± 94, 103 ± 58, and 92 ± 59 cm 2 for men; 121 ± 61, 109 ± 65, and 94 ± 53 cm 2 for women; both P 2 for men; 162 ± 66, 141 ± 60, and 116 ± 54 cm 2 for women; both P 2 ) men ( r = 024 for intermuscular fat, r = 037 for visceral abdominal fat, both P r = 020 for intermuscular fat, r = 040 for visceral abdominal fat, both P CONCLUSIONS —Elderly men and women with normal body weight may be at risk for metabolic abnormalities, including type 2 diabetes, if they possess an inordinate amount of muscle fat or visceral abdominal fat

The PedsQL™ in Type 1 and Type 2 Diabetes: Reliability and validity of the Pediatric Quality of Life Inventory™ Generic Core Scales and Type 1 Diabetes Module

Abstract: OBJECTIVE —The Pediatric Quality of Life Inventory (PedsQL) is a modular instrument designed to measure health-related quality of life (HRQOL) in children and adolescents aged 2–18 years. The PedsQL 4.0 Generic Core Scales are child self-report and parent proxy-report scales developed as the generic core measure to be integrated with the PedsQL disease-specific modules. The PedsQL 3.0 Type 1 Diabetes Module was designed to measure diabetes-specific HRQOL. RESEARCH DESIGN AND METHODS —The PedsQL Generic Core Scales and Diabetes Module were administered to 300 pediatric patients with type 1 or type 2 diabetes and 308 parents. RESULTS —Internal consistency reliability for the PedsQL Generic Core Total Scale score (α = 0.88 child, 0.89 parent-report) and most Diabetes Module scales (average α = 0.71 child, 0.77 parent-report) was acceptable for group comparisons. The PedsQL 4.0 distinguished between healthy children and children with diabetes. The Diabetes Module demonstrated intercorrelations with dimensions of generic and diabetes-specific HRQOL. CONCLUSIONS —The results demonstrate the reliability and validity of the PedsQL in diabetes. The PedsQL may be used as an outcome measure for diabetes clinical trials and research.

Depression predicts increased incidence of adverse health outcomes in older Mexican Americans with type 2 diabetes.

Abstract: OBJECTIVE —To examine the separate and combined effects of depression and diabetes on the incidence of adverse health outcomes among older Mexican Americans. RESEARCH DESIGN AND METHODS —Longitudinal data from the Hispanic Established Population for the Epidemiologic Study of the Elderly (EPESE) survey were used to examine the main effects and interaction effects of diabetes and depressive symptoms (measured with the Center for Epidemiologic Study of Depression) or clinical diagnostic criteria (measured with the Composite International Diagnostic Interview Depression Module) on the development of macrovascular complications (including cardiovascular disease, stroke, and kidney disease), microvascular complications (including nephropathy, neuropathy, retinopathy, and amputations), functional disability, and mortality over 7 years in a sample of 2,830 Mexican Americans aged ≥65 years. RESULTS —The interaction of diabetes and depression was found to be synergistic, predicting greater mortality, greater incidence of both macro- and microvascular complications, and greater incidence of disability in activities of daily living, even when controlling for sociodemographic characteristics such as sex, age, education, acculturation, and marital status. Importantly, this interaction was found to predict not only greater incidence but also earlier incidence of adverse events in older adults. CONCLUSIONS —Whether a marker for underlying disease severity, an indicator of diminished self-care motivation, or the result of physiologic changes, the interaction of depression and diabetes has a synergistic effect on the health of older Mexican Americans, increasing the risk for poor outcomes. This is of particular clinical importance because although depression is often underrecognized in older adults, effective treatment is available and can result in improved medical outcomes.

Lowering the Criterion for Impaired Fasting Glucose Is in Order

Abstract: Editor’s comment: Because of the controversial nature of the new lowered criterion for IFG, I offered the Chairman of the Expert Committee an opportunity to respond to my commentary on the subject. I would only point out that Dr. Genuth’s reference 8 shows an association between glycemia and cardiovascular disease (as have many other reports), but to date, five prospective studies, analyzed either singly or as a metanalysis, have been unable to demonstrate a beneficial effect of lowering glycemia on cardiovascular disease outcomes.

Frequency of severe hypoglycemia requiring emergency treatment in type 1 and type 2 diabetes: a population-based study of health service resource use.

Abstract: OBJECTIVE —To determine the incidence, predisposing factors, and costs of emergency treatment of severe hypoglycemia in people with type 1 and type 2 diabetes. RESEARCH DESIGN AND METHODS —Over a 12-month period, routinely collected datasets were analyzed in a population of 367,051 people, including 8,655 people with diabetes, to measure the incidence of severe hypoglycemia that required emergency assistance from Ninewells Hospital and Medical School (NHS) personnel including those in primary care, ambulance services, hospital accident and emergency departments, and inpatient care. Associated costs with these episodes were calculated. RESULTS —A total of 244 episodes of severe hypoglycemia were recorded in 160 patients, comprising 69 (7.1%) people with type 1 diabetes, 66 (7.3%) with type 2 diabetes treated with insulin, and 23 (0.8%) with type 2 diabetes treated with sulfonylurea tablets. Incidence rates were 11.5 and 11.8 events per 100 patient-years for type 1 and type 2 patients treated with insulin, respectively. Age, duration, and socioeconomic status were identified as risk factors for severe hypoglycemia. One in three cases were treated solely by the ambulance service with no other contact from health care professionals. The total estimated cost of emergency treatment of severe hypoglycemia was ≤£92,078 in one year. CONCLUSIONS —Hypoglycemia requiring emergency assistance from health service personnel is as common in people with type 2 diabetes treated with insulin as in people with type 1 diabetes. It is associated with considerable NHS resource use that has a significant economic and personal cost.