Providing an intensive weight management program in routine primary care may help patients with type 2 diabetes achieve remission, a recent study found.
As part of DiRECT (Diabetes Remission Clinical Trial), a cluster-randomized trial, 49 primary care practices in Scotland and England were randomly assigned to provide a weight management intervention (n=23) or to serve as controls by providing best-practice care according to guidelines (n=26). Researchers enrolled 298 participants from the practices and placed 149 into each group. Participants were ages 20 to 65 years, had received a diagnosis of type 2 diabetes within the past six years, had body mass indexes between 27 and 45 kg/m2, and were not taking insulin.
As part of the intervention, the practices' dietitians or trained nurses replaced participants' diets with formula (about 850 kcal/d) for three to five months. They then reintroduced food over a period of two to eight weeks before providing structured support for long-term weight-loss maintenance. Intervention participants also discontinued antidiabetic and antihypertensive medications (and only restarted the latter if systolic blood pressure rose above 140 mm Hg).
Primary outcomes at 12 months were weight loss of 15 kg or more and diabetes remission, defined as an HbA1c less than 6.5% at least two months after discontinuing all antidiabetic medications. Results were published online on Dec. 5, 2017, by The Lancet.
At the end of 12 months, 36 intervention participants (24%) lost 15 kg or more, compared to no participants in the control group (P<0.0001). The researchers had determined beforehand that a remission rate of 22% would be clinically important, and 68 (46%) intervention participants achieved diabetes remission, compared to six (4%) control participants (odds ratio, 19.7; 95% CI, 7.8 to 49.8; P<0.0001).
Diabetes remission was associated with the amount of weight lost. Remission was achieved by none of the 76 participants who gained weight, six (7%) of 89 who maintained 0- to 5-kg weight loss, 19 (34%) of 56 who lost 5 to 10 kg, 16 (57%) of 28 who lost 10 to 15 kg, and 31 (86%) of 36 who lost at least 15 kg. In addition, 68% of the intervention group remained off antihypertensive medications at the end of follow-up, with no increase in mean blood pressure.
The study authors noted limitations, such as a potential lack of generalizability to racial groups who tend to develop diabetes with less weight gain than others, such as South Asians. They added that they did not assess body composition in detail and that participants were aware of their group assignments.
A comment noted that although the study's main limitation is its duration (yet follow-up will continue to four years), the results suggest that a nonpharmacological approach to diabetes should be revived. “The DiRECT study indicates that the time of diabetes diagnosis is the best point to start weight reduction and lifestyle changes because motivation of a patient is usually high and can be enhanced by the professional health-care providers,” the editorialist wrote.