In type 2 diabetes, a primary careled weight management program increased weight loss and diabetes remission at 2 years

Abstract

Question In patients with type 2 diabetes, does a primary careled weight management program increase remission rates and weight loss at 2 years compared with usual care? Methods Design Cluster randomized controlled trial (Diabetes Remission Clinical Trial [DiRECT]). ISRCTN03267836. Allocation {Concealed}*. Blinding Blinded (statisticians). Follow-up period 2 years. Setting 55 primary care practices in England and Scotland. 49 practices (89%) recruited patients. Patients 306 patients 20 to 65 years of age (mean age 54 y, 59% men, mean hemoglobin [Hb] A1c level 7.8% [62 mmol/mol], mean weight 100 kg in the intention-to-treat [ITT] population) who had type 2 diabetes mellitus diagnosed in the past 6 years and body mass index 27 to 45 kg/m2. Exclusion criteria included current use of insulin, HbA1c 12% (108 mmol/mol), recent estimated glomerular filtration rate <30 mL/min/1.732 m2, or weight loss >5 kg in the past 6 months. Intervention Structured weight management program (Counterweight-Plus) led by trained dieticians or nurses in primary care and including antidiabetes and antihypertensive drug withdrawal, total diet replacement with a diet of 825 to 853 kcal/d for 3 to 5 months, stepped food reintroduction for up to 8 weeks, and weight loss maintenance for the remainder of the trial with structured support, including monthly appointments as needed and rescue plans for weight regain (n =23 practices, n =157 patients); or usual care (n =26 practices, n =149 patients). Outcomes Primary outcomes were weight loss 15 kg and diabetes remission (HbA1c <6.5% [<48 mmol/mol] after baseline withdrawal of antidiabetes drugs). Patient follow-up 89% had data at 2 years. 97% were included in the ITT analysis. It was assumed that patients with missing data did not meet primary outcome criteria. Main results The main results are in the Table. Conclusion In type 2 diabetes, a primary careled weight management program increased rates of weight loss 15 kg and diabetes remission at 2 years compared with usual care. Primary careled weight management program vs usual care in patients with type 2 diabetes Outcomes Event rates At 2 y Weight management program Usual care RBI (95% CI) NNT (CI) Weight loss 15 kg 11% 2.0% 563% (101 to 1690) 9 (3 to 50) Diabetes remission (HbA1c <6.5%) 36% 3.4% 1300% (562 to 2076) 3 (2 to 6) Mean change from baseline Adjusted mean difference (CI) Weight loss, kg 7.6 2.3 5.4 (6.9 to 4.0) HbA1c, % 0.5% 0% 0.44% (0.76 to 0.13) Hb = hemoglobin; other abbreviations defined in Glossary. RBI, NNT, and CI calculated from usual care event rates and adjusted odds ratios in article. Odds ratios were adjusted for study region and practice list size with a random effect for practice; mean differences were adjusted for baseline outcome values, age, sex, diabetes duration, baseline HbA1c level, study region, practice list size, and general practitioner practice. Commentary The 2-year results of DiRECT support the hypothesis that intensive behavior modification for weight loss can lead to sustained remission in early-stage diabetes. The 2-year diabetes remission rate is similar to the 40% achieved with Roux-en-Y gastric bypass surgery (1). Primary care practices that expect to adopt this intervention will need a dietician or practice nurse to deliver an intensive weight loss program with total diet replacement and can anticipate problems getting patients to join and remain in the program. In DiRECT, 1087 of 1510 potentially eligible patients either declined or did not respond. 306 of the remaining 423 patients met all inclusion criteria. Of the 157 patients enrolled in the weight management intervention, 32 (20%) withdrew from treatment by 12 months and 48 (31%) by 24 months. The cost-effectiveness of the DiRECT intervention vs usual care was assessed at 1 year (2). The intervention may be more cost-effective than gastric bypass surgery or a lifetime of medications for diabetes, but such analyses have not yet been published. However, the DiRECT approach could be perceived as limiting patients self-efficacy to integrate the necessary behavioral changes into their daily lives to sustain weight loss in the long-term. Additional research may be needed to help us empower our patients to view their relation to food as one linked to appetite instead of cycles of weight suppression, disinhibition, and weight gain (3) and to better manage their own food-related behaviors to reduce risk for diabetes.