Intensive primary care weight-loss program results in remission for half of patients with T2DM (DiRECT)

Reference

Lean ME, Leslie WS, Barnes AC, et al. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet 2018;391(10120):541-551

Synopsis

These authors from the Diabetes Remission Clinical Trial (DiRECT) randomized (concealed allocation) 49 primary care practices in Scotland and in the Tyneside region of England to provide a commercial weight-management program (Counterweight Plus) or a control intervention. From within these practices the researchers recruited 306 adults with type 2 diabetes (duration less than 6 years) who had a body mass index between 27 and 45 and were not using insulin. There was no random sampling of patients within each practice. The weight-management program consisted of training the office nurse or dietitian in Counterweight Plus—dietary replacement for 3 months to 5 months using a low-energy formula, followed by 2 weeks to 8 weeks of food re-introduction. The patients in this program stopped taking all oral diabetes drugs and antihypertensive drugs at the beginning of the study. The goal of the intervention was to induce at least 15 kilograms of weight loss. The patients in the intervention groups were asked to not increase their physical activity. The control intervention was best-practice care using the United Kingdom National Institute for Clinical Excellence guidelines. The authors report outcomes data after 1 year in the program. Twenty-one (14%) of the intervention patients did not complete the 12-month assessment compared with 2 (1%) of the control patients. At the final assessment, 36 intervention patients (24%) had lost at least 15 kilograms compared with none of the control patients. Diabetes remission, as defined as a hemoglobin A1C level of less than 6.5% (48 mmol/mol) after at least 2 months off all antidiabetic medications, was achieved in 45% of intervention patients compared with 4% of control patients (number needed to treat = 3; 95% CI 2 - 4). The authors also report that quality of life improved in the intervention group and deteriorated in the control group. Approximately 20% of the patients dropped out of the intervention, and 4% of the intervention participants reported serious adverse events (including biliary colic) compared with 1% of control participants (number needed to treat to harm = 30). It is unclear if the benefit persists 5 years after resuming food. Although the study was government funded, the Counterweight Plus website suggests that there is potential economic gain for those who deliver the service (http://www.counterweight.org/What-We-Offer/Health-Professionals-151).