DiRECT trial: New findings that suggest that losing weight and being in remission from TD can improve heart health

Diabetes UK | April  2021 | DUKPC research highlights: day 2

At this year’s Diabetes UK Professional Conference (DUKPC), Professor Roy Taylor, from the University of Newcastle discussed his latest findings from the DiRECT trial. Funded by Diabetes UK, the DiRECT trial ( Diabetes Remission Clinical Trial) has been led by Professor Taylor and his colleagues for the last decade. At this year’s online conference Prof Taylor shared new findings that indicate weight loss and going into remission could reduce the risk of heart disease.

29 participants with type 2 diabetes from the trial were analysed to explore how losing weight and going into remission affects risk of heart disease. The researcher used a risk calculator, which combines information on a range of different factors linked with heart disease to predict the risk of having a heart attack or stroke. 

Image source: Diabetes UK Description: Visual summary of the latest DiRECT findings

Six months later, all the participants experienced a reduction in weight and had less internal body fat, and this lowered their risk of heart disease. But the reduction in risk was most pronounced for people who had put their type 2 diabetes in remission compared to those who were not in remission. This gives us early evidence that being in remission could help to protect against heart attacks and strokes later in life. The findings also show that weight loss on its own can benefit health, even if you don’t go into remission.  

This research is really encouraging and builds a picture of how remission can offer people with type 2 diabetes a chance of a better quality of life, without the complications of diabetes. But there’s still more we need to find out about how much remission can protect people against diabetes complications. That’s why it’s important to keep on getting regular health checks even when you are in remission to make sure that any new, or existing complications, can be monitored and treated.  (Source: Diabetes UK)

Full details are available from Diabetes UK

See also: Newcastle University Reversing Type 2 Diabetes and ongoing remission

Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial

Lean, M. E. et al |2019| Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial| The Lancet Diabetes & Endocrinology.

scale-diet-fat-health-53404.jpegSummary

Background

The DiRECT trial assessed remission of type 2 diabetes during a primary care-led weight-management programme. At 1 year, 68 (46%) of 149 intervention participants were in remission and 36 (24%) had achieved at least 15 kg weight loss. The aim of this 2-year analysis is to assess the durability of the intervention effect.

Methods

DiRECT is an open-label, cluster-randomised, controlled trial done at primary care practices in the UK. Practices were randomly assigned (1:1) via a computer-generated list to provide an integrated structured weight-management programme (intervention) or best-practice care in accordance with guidelines (control), with stratification for study site (Tyneside or Scotland) and practice list size (more than 5700 or more than or equal to5700 people). Allocation was concealed from the study statisticians; participants, carers, and study research assistants were aware of allocation. We recruited individuals aged 20–65 years, with less than 6 years’ duration of type 2 diabetes, BMI 27–45 kg/m 2, and not receiving insulin between July 25, 2014, and Aug 5, 2016. The intervention consisted of withdrawal of antidiabetes and antihypertensive drugs, total diet replacement (825–853 kcal per day formula diet for 12–20 weeks), stepped food reintroduction (2–8 weeks), and then structured support for weight-loss maintenance. The coprimary outcomes, analysed hierarchically in the intention-to-treat population at 24 months, were weight loss of at least 15 kg, and remission of diabetes, defined as HbA 1c less than 6·5% (48 mmol/mol) after withdrawal of antidiabetes drugs at baseline (remission was determined independently at 12 and 24 months). The trial is registered with the ISRCTN registry, number 03267836, and follow-up is ongoing.

Findings

The intention-to-treat population consisted of 149 participants per group. At 24 months, 17 (11%) intervention participants and three (2%) control participants had weight loss of at least 15 kg and 53 (36%) intervention participants and five (3%) control participants had remission of diabetes. The adjusted mean difference between the control and intervention groups in change in bodyweight was −5·4 kg and in HbA 1c was −4·8 mmol/mol, despite only 51 (40%) of 129 patients in the intervention group using anti-diabetes medication compared with 120 (84%) of 143 in the control group. In a post-hoc analysis of the whole study population, of those participants who maintained at least 10 kg weight loss (45 of 272 with data), 29 (64%) achieved remission; 36 (24%) of 149 participants in the intervention group maintained at least 10 kg weight loss. Serious adverse events were similar to those reported at 12 months, but were fewer in the intervention group than in the control group in the second year of the study (nine vs 22).

Interpretation

The DiRECT programme sustained remissions at 24 months for more than a third of people with type 2 diabetes. Sustained remission was linked to the extent of sustained weight loss.

The Library & Knowledge Service can provide access to this article for Rotherham NHS Staff, request a copy here 

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