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Weight Management for Remission of Type 2 Diabetes
Study Questions:
Can intensive weight management within routine primary care achieve remission of type 2 diabetes?
Methods:
An open-label, cluster-randomized trial (DiRECT) was conducted in 49 primary care practices in Scotland and the Tyneside region of England. Practices were randomly assigned (1:1), via a computer-generated list, to provide either a weight management program (intervention) or best-practice care by guidelines (control), with stratification for study site and practice size (>5,700 or ≤5,700). Participants, caregivers, and research assistants who collected outcome data were aware of group allocation; however, allocation was concealed from the study statistician. Recruits included those ages 20–65 years who had been diagnosed with type 2 diabetes within the past 6 years, body mass index (BMI) 27–45 kg/m2, and not receiving insulin. 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. Co-primary outcomes were weight loss of ≥15 kg, and remission of diabetes, defined as hemoglobin A1c of <6.5% after ≥2 months off all antidiabetic medications, from baseline to 12 months. Outcomes were analyzed hierarchically.
Results:
About 40% were female, mean age was 54 years, BMI was 35 (standard deviation 4) kg/m2, >60% were on statins, 56% had hypertension, and mean hemoglobin A1c was 7.6 (1.25)%. A total of 306 individuals were from 49 intervention (n = 23) and control (n = 26) general practices; 149 participants per group comprised the intention-to-treat population. At 12 months, weight loss of ≥15 kg occurred in 36 (24%) in the intervention group and none in the control group (p < 0.0001). Diabetes remission was achieved in 68 (46%) in the intervention group and six (4%) in the control group (odds ratio, 19.7; 95% confidence interval [CI], 7.8–49.8; p < 0.0001). Remission varied with weight loss in the whole study population, with achievement in none of 76 participants who gained weight, 7% of 89 participants who maintained 0–5 kg weight loss, 34% of 56 participants with 5–10 kg loss, 57% of 28 participants with 10–15 kg loss, and 86% of 36 participants who lost ≥15 kg. Mean bodyweight fell by 10.0 kg (8.0) in the intervention group and 1.0 kg (3.7) in the control group (adjusted difference, –8.8 kg; 95% CI, –10.3 to –7.3; p < 0.0001). Nine serious adverse events were reported by 4% of the intervention group and 1% in the control group. No serious adverse events led to withdrawal from the study.
Conclusions:
At 12 months following an intensive weight management program in a primary care setting, almost one half of participants achieved remission to a nondiabetic state and off antidiabetic drugs. Remission of type 2 diabetes is a practical target for primary care.
Perspective:
While only 20% of those eligible agreed to participate and participation bias is likely, the number of dropouts in this intensive weight loss program was very low, and results were very impressive, particularly since each clinic had few patients. Mean weight loss at 1 year was about 10% of baseline weight with the intervention and <1% in the controls. Diet was the major factor to explain the results. During food reintroduction and weight loss maintenance, participants were advised on strategies to raise physical activity towards a target of 15,000 steps per day. Objectively measured physical activity showed no increase in physical activity in either group between baseline and 12 months. Considering the difference in cost and side effects, it would be interesting to see this group compare the intense weight loss protocol with bariatric surgery in moderately obese diabetic patients.
Keywords: Antihypertensive Agents, Body Mass Index, Diabetes Mellitus, Type 2, Diet, Exercise, General Practice, Glycated Hemoglobin A, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Hypertension, Hypoglycemic Agents, Insulin, Obesity, Primary Prevention, Primary Health Care, Weight Loss, Weight Reduction Programs
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