ContextObservational studies suggest that surgically induced loss of weight may be effective therapy for type 2 diabetes.ObjectiveTo determine if surgically induced weight loss results in better glycemic control and less need for diabetes medications than conventional approaches to weight loss and diabetes control.Design, Setting, and Participants
 Unblinded randomized controlled trial conducted from December 2002 through December 2006 at the University Obesity Research Center in Australia, with general community recruitment to established treatment programs. Participants were 60 obese patients (BMI >30 and <40)
 with recently diagnosed (<2 years) type 2 diabetes.
 InterventionsConventional diabetes therapy with a focus on weight loss by lifestyle change vs laparoscopic adjustable gastric banding with conventional diabetes care.Main Outcome Measures
 Remission of type 2 diabetes (fasting glucose level <126
 mg/dL [7.0 mmol/L] and glycated hemoglobin [HbA1c] value <6.2% while taking no glycemic therapy). Secondary measures included weight and components of the metabolic syndrome. Analysis was by intention-to-treat.
 Results
 Of the 60 patients enrolled, 55 (92%) completed the 2-year follow-up.
 Remission of type 2 diabetes was achieved by 22 (73%) in the surgical group and 4 (13%) in the conventional-therapy group. Relative risk of remission for the surgical group was 5.5 (95% confidence interval,
 2.2-14.0). Surgical and conventional-therapy groups lost a mean (SD)
 of 20.7% (8.6%) and 1.7% (5.2%) of weight, respectively, at 2 years (P < .001). Remission of type 2 diabetes was related to weight loss (R2 = 0.46, P < .001) and lower baseline HbA1c levels (combined R2 = 0.52, P < .001). There were no serious complications in either group.
 Conclusions
 Participants randomized to surgical therapy were more likely to achieve remission of type 2 diabetes through greater weight loss.
 These results need to be confirmed in a larger, more diverse population and have long-term efficacy assessed.
 Trial Registration
 actr.org Identifier: ACTRN012605000159651

/pdf/adjustable-gastric-banding-and-conventional-therapy-for-type-4xufsbvx9n.pdf

Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial.

Objectives: to assess the clinical effectiveness and cost-effectiveness of bariatric surgery for obesity. Data sources: seventeen electronic databases were searched [MEDLINE; EMBASE; PreMedline In-Process & Other Non-Indexed Citations; The Cochrane Library including the Cochrane Systematic Reviews Database, Cochrane Controlled Trials Register, DARE, NHS EED and HTA databases; Web of Knowledge Science Citation Index (SCI); Web of Knowledge ISI Proceedings; PsycInfo; CRD databases; BIOSIS; and databases listing ongoing clinical trials] from inception to August 2008. Bibliographies of related papers were assessed and experts were contacted to identify additional published and unpublished references Review methods: two reviewers independently screened titles and abstracts for eligibility. Inclusion criteria were applied to the full text using a standard form. Interventions investigated were open and laparoscopic bariatric surgical procedures in widespread current use compared with one another and with non-surgical interventions. Population comprised adult patients with body mass index (BMI) ? 30 and young obese people. Main outcomes were at least one of the following after at least 12 months follow-up: measures of weight change; quality of life (QoL); perioperative and postoperative mortality and morbidity; change in obesity-related comorbidities; cost-effectiveness. Studies eligible for inclusion in the systematic review for comparisons of Surgery versus Surgery were RCTs. For comparisons of Surgery versus Non-surgical procedures eligible studies were RCTs, controlled clinical trials and prospective cohort studies (with a control cohort). Studies eligible for inclusion in the systematic review of cost-effectiveness were full cost-effectiveness analyses, cost-utility analyses, cost-benefit analyses and cost-consequence analyses. One reviewer performed data extraction, which was checked by two reviewers independently. Two reviewers independently applied quality assessment criteria and differences in opinion were resolved at each stage. Studies were synthesised through a narrative review with full tabulation of the results of all included studies. In the economic model the analysis was developed for three patient populations, those with BMI ? 40; BMI ? 30 and Results: a total of 5386 references were identified of which 26 were included in the clinical effectiveness review: three randomised controlled trials (RCTs) and three cohort studies compared surgery with non-surgical interventions and 20 RCTs compared different surgical procedures. Bariatric surgery was a more effective intervention for weight loss than non-surgical options. In one large cohort study weight loss was still apparent 10 years after surgery, whereas patients receiving conventional treatment had gained weight. Some measures of QoL improved after surgery, but not others. After surgery statistically fewer people had metabolic syndrome and there was higher remission of Type 2 diabetes than in non-surgical groups. In one large cohort study the incidence of three out of six comorbidities assessed 10 years after surgery was significantly reduced compared with conventional therapy. Gastric bypass (GBP) was more effective for weight loss than vertical banded gastroplasty (VBG) and adjustable gastric banding (AGB). Laparoscopic isolated sleeve gastrectomy (LISG) was more effective than AGB in one study. GBP and banded GBP led to similar weight loss and results for GBP versus LISG and VBG versus AGB were equivocal. All comparisons of open versus laparoscopic surgeries found similar weight losses in each group. Comorbidities after surgery improved in all groups, but with no significant differences between different surgical interventions. Adverse event reporting varied; mortality ranged from none to 10%. Adverse events from conventional therapy included intolerance to medication, acute cholecystitis and gastrointestinal problems. Major adverse events following surgery, some necessitating reoperation, included anastomosis leakage, pneumonia, pulmonary embolism, band slippage and band erosion. Bariatric surgery was cost-effective in comparison to non-surgical treatment in the reviewed published estimates of cost-effectiveness. However, these estimates are likely to be unreliable and not generalisable because of methodological shortcomings and the modelling assumptions made. Therefore a new economic model was developed. Surgical management was more costly than non-surgical management in each of the three patient populations analysed, but gave improved outcomes. For morbid obesity, incremental cost-effectiveness ratios (ICERs) (base case) ranged between £2000 and £4000 per QALY gained. They remained within the range regarded as cost-effective from an NHS decision-making perspective when assumptions for deterministic sensitivity analysis were changed. For BMI ? 30 and Conclusions: bariatric surgery appears to be a clinically effective and cost-effective intervention for moderately to severely obese people compared with non-surgical interventions. Uncertainties remain and further research is required to provide detailed data on patient QoL; impact of surgeon experience on outcome; late complications leading to reoperation; duration of comorbidity remission; resource use. Good-quality RCTs will provide evidence on bariatric surgery for young people and for adults with class I or class II obesity. New research must report on the resolution and/or development of comorbidities such as Type 2 diabetes and hypertension so that the potential benefits of early intervention can be assessed.

/pdf/the-clinical-effectiveness-and-cost-effectiveness-of-uew41hb9iv.pdf

The clinical effectiveness and cost-effectiveness of bariatric (weight loss) surgery for obesity: a systematic review and economic evaluation

https://aasldpubs.onlinelibrary.wiley.com/doi/pdf/10.1002/hep.20251

Nonalcoholic fatty liver disease: Improvement in liver histological analysis with weight loss.

https://www.soard.org/article/S1550-7289(08)00630-8/pdf

American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery Medical Guidelines for Clinical Practice for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient.

In 2012, an expert panel composed of presidents of each of the societies, the European Chapter of the International Federation for the Surgery of Obesity (IFSO-EC), and of the European Association for the Study of Obesity (EASO), as well as of the chair of EASO Obesity Management Task Force (EASO OMTF) and other key representatives from IFSO-EC and EASO, devoted the joint Medico-Surgical Workshop of both institutions to the topic of metabolic surgery in advance of the 2013 European Congress on Obesity held in Liverpool. This meeting was prompted by the extraordinary advancement made in the field of metabolic and bariatric surgery during the past decade. It was agreed to revise and update the 2008 Interdisciplinary European Guidelines on Surgery of Severe Obesity produced by focusing in particular on the evidence gathered in relation to the effects on diabetes and the changes in the recommendations of patient eligibility criteria. The expert panel allowed the coverage of key disciplines in the comprehensive management of obesity and obesity-associated diseases, aimed specifically at updating the clinical guidelines to reflect current knowledge, expertise and evidence-based data on metabolic and bariatric surgery.

/pdf/interdisciplinary-european-guidelines-on-metabolic-and-27zdvg7efw.pdf

John Ham

Papers

Laparoscopic adjustable gastric banding in the treatment of obesity: a systematic literature review.