Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial

TLDR: The findings show that, at 12 months, almost half of participants achieved remission to a non-diabetic state and off antidiabetic medications, from baseline to 12 months.

About: This article is published in The Lancet.The article was published on 2017-12-05 and is currently open access. It has received 1101 citations till now. The article focuses on the topics: Weight loss & Type 2 diabetes.

Figures

Table 2: Key secondary and other outcomes

Table 3: Serious Adverse Events

Figure 1: Trial Profile

Figure 2: Primary outcomes and remission of diabetes in relation to weight loss at 12 months. A: First co-primary outcome, achievement of ≥15kg weight loss at 12 months, by randomised group. B: Second co-primary outcome, remission of diabetes (HbA1c <48mmol/mol, off anti-diabetic medication for 2 months), by randomised group. C: Remission of diabetes, in relation to weight loss achieved at 12 months (both randomised groups combined).

Table 1: Baseline characteristics

Fig 3: Changes in weight of participants who remained in the trial and those who dropped out during each phase of the intervention

Frequently asked questions

Q1. What are the contributions mentioned in the paper "Primary care weight-management for type 2 diabetes: the cluster- randomised diabetes remission clinical trial (direct)" ?

The Diabetes Remission Clinical Trial ( DiRECT ) this paper evaluated whether effective weight management, delivered in the primary care setting, could produce sustained remission of type 2 diabetes. 

Q2. What are the future works in "Primary care weight-management for type 2 diabetes: the cluster- randomised diabetes remission clinical trial (direct)" ?

It will be possible to determine the effects of DiRECT intervention by future analysis of the national retinopathy screening databases. Further detailed analysis of medication and dosage changes could be possible. 

Q3. What is the main purpose of the study?

The intervention comprised withdrawal of antidiabetic and antihypertensive drugs, total diet replacement (825–853 kcal/day formula diet for 3–5 months), stepped food reintroduction (2–8 weeks), and structured support for long-term weight loss maintenance. 

Q4. What is the primary outcome of the diabetes remission clinical trial?

Co-primary outcomes were weight loss of 15 kg or more, and remission of diabetes, defined as glycated haemoglobin (HbA1c) of less than 6·5% (<48 mmol/mol) after at least 2 months off all antidiabetic medications, from baseline to 12 months. 

Q5. How many participants in the intervention group were reported to have serious adverse events?

Nine serious adverse events were reported by seven (4%) of 157 participants in the intervention group and two were reported by two (1%) participants in the control group. 

Q6. how many participants achieved remission of type 2 diabetes?

Diabetes remission was achieved in 68 (46%) participants in the intervention group and six (4%) participants in the control group (odds ratio 19·7, 95% CI 7·8–49·8; p<0·0001). 

Q7. What is the remission of type 2 diabetes?

The authors recruited individuals aged 20–65 years who had been diagnosed with type 2 diabetes within the past 6 years, had a body-mass index of 27–45 kg/m2, and were not receiving insulin. 

Q8. how much did the intervention group improve?

Quality of life, as measured by the EuroQol 5 Dimensions visual analogue scale, improved by 7·2 points (SD 21·3) in the intervention group, and decreased by 2·9 points (15·5) in the control group (adjusted difference 6·4 points, 95% CI 2·5–10·3; p=0·0012).