Type 2 diabetes remission possible with Weight loss programme: DIRECT TRIAL
Diabetes is a growing burden, 37.3 million Americans, or 11.3% of the population, had diabetes in 2019. Diagnosed and undiagnosed, of the 37.3 million adults with diabetes, 28.7 million were diagnosed, and 8.5 million were undiagnosed.
The DiRECT trial published in The Lancet- Diabetes and Endocrinology, 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.
DiRECT an open-label, cluster-randomised, controlled trial were practices were randomly assigned (1:1) via a computer-generated list to provide an integrated structured weight-management programme. Allocation was concealed from the study statisticians; participants, carers, and study research assistants were aware of allocation. Individuals aged 20–65 years,were included in the study with less than 6 years' duration of type 2 diabetes, BMI 27–45 kg/m2, and not receiving insulin between July 25, 2014, and Aug 5, 2016. The co primary 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 HbA1c less than 6•5% (48 mmol/mol) after withdrawal of antidiabetes drugs at baseline (remission was determined independently at 12 and 24 months).
The results of the study were
• There were 149 participants per group. At 24 months, 11% intervention participants and 2% control participants had weight loss of at least 15 kg, adjusted odds ratio [aOR] 7•49, and 53 (36%) intervention participants and five (3%) control participants had remission.
• The adjusted mean difference between the control and intervention groups in change in bodyweight was −5•4 kg and in HbA1c 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).
Researchers concluded that "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."
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