Johansen MY, et al. – This paper investigated whether an intensive lifestyle intervention led to equivalent glycemic control compared with standard care and, secondarily, caused a reduction in glucose–lowering medication in patients with type 2 diabetes. It was disclosed that among those diagnosed for less than 10 years, a lifestyle intervention compared with standard care caused a change in glycemic control which did not reach the criterion for equivalence. Nevertheless, it appeared to be in a direction consistent with benefit. In order to examine the superiority, generalizability and durability of the results, advanced research was warranted.

Methods

• The design of this research was a randomized, assessor-blinded, single-center study within Region Zealand and the Capital Region of Denmark (April 2015-August 2016).
• The enrollment consisted of 98 adults with non–insulin-dependent type 2 diabetes who were diagnosed for less than 10 years.
• They were randomly assigned (2:1; stratified by sex) to the lifestyle group (n = 64) or the standard care group (n = 34).
• The enrollees received standard care with individual counseling and standardized, blinded, target-driven medical therapy.
• The lifestyle intervention encompassed 5 to 6 weekly aerobic training sessions (duration 30-60 minutes), of which 2 to 3 sessions were combined with resistance training.
• The lifestyle participants received dietary plans targeting a body mass index of 25 or less.
• The candidates were followed up for 12 months.
• The primary outcome constituted change in hemoglobin A1c (HbA1c) from baseline to 12-month follow-up, and equivalence was prespecified by a CI margin of ±0.4% based on the intention-to-treat population.
• Superiority analysis was carried out on the secondary outcome reductions in glucose-lowering medication.

Results

• Among 98 randomized participants (mean age, 54.6 years [SD, 8.9]; women, 47 [48%]; mean baseline HbA1c, 6.7%), 93 individuals completed the trial.
• 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 in change of -0.26% [95% CI, -0.52% to 0.01%]), not meeting the criteria for equivalence (P = .15), from baseline to 12-month follow-up.
• Reduction in glucose-lowering medications occurred in 47 enrollees (73.5%) in the lifestyle group and 9 participants (26.4%) in the standard care group (difference, 47.1 percentage points [95% CI, 28.6-65.3]).
• 32 adverse events (most commonly musculoskeletal pain or discomfort and mild hypoglycemia) were reported in the lifestyle group and 5 in the standard care group.