Among adults with type 2 diabetes for less than 10 years, intensive lifestyle intervention does not meet the criterion for equivalence for glycemic control compared with standard care, but it is consistent with benefit, according to a study published in JAMA. In addition, lifestyle intervention led to a substantial and parallel reduction in the use of glucose-lowering medication.
Mette Yun Johansen, MSc, from the Center of Inflammation and Metabolism at the University of Denmark in Copenhagen, and colleagues conducted a randomized clinical trial from April 2015 to August 2016.
Participants were recruited through the Danish Diabetes Association. Inclusion criteria were type 2 diabetes diagnosed less than 10 years, body mass index (BMI) of 25 to 40, and taking 2 or fewer glucose-lowering medications. At least 6 weeks prior to baseline measurements, all participants had their glucose-lowering, lipid-lowering, and blood pressure–lowering medications titrated to obtain prespecified treatment targets. Patients were randomized in blocks of 3 and 6, stratified by sex, to either the lifestyle group or the standard care group in a 2:1 ratio.
All participants received standard care with individual counseling and target-driven medical therapy. Additionally, the lifestyle intervention included 5 to 6 weekly aerobic training sessions (duration 30 to 60 minutes), of which 2 to 3 sessions were combined with resistance training. The lifestyle participants received dietary plans targeted at a BMI of 25 or less. Participants were followed up for 12 months. The primary outcome was change in hemoglobin A1c (HbA1c) from baseline to follow-up.
Among 98 randomized participants (mean age, 54.6 years; mean baseline HbA1c, 6.7%), 93 participants completed the trial. From baseline to 12-month follow-up, the mean HbA1c level changed from 6.65% to 6.34% in the lifestyle group and from 6.74% to 6.66% in the standard care group (mean between-group difference −0.26%), which did not meet the criteria for equivalence. Reduction in glucose-lowering medications occurred in 47 participants (73.5%) in the lifestyle group and 9 participants (26.4%) in the standard care group (difference, 47.1%). There were 32 adverse events (including musculoskeletal pain or discomfort and mild hypoglycemia) in the lifestyle group and 5 in the standard care group.
“The main finding was that an intensive lifestyle intervention was nonequivalent compared with standard care in relation to maintaining glycemic control, with the modest reduction in HbA1c favoring the lifestyle group,” said the authors. “Additionally, the lifestyle intervention led to a substantial and parallel reduction in glucose-lowering medication.”
- Johansen MY, MacDonald CS, Hansen KB, et al. Effect of an intensive lifestyle intervention on glycemic control in patients with type 2 diabetes: A randomized clinical trial. JAMA. 15 August 2017. doi:10.1001/jama.2017.10169