Type 2 diabetes remission one year after an intensive lifestyle intervention: A secondary analysis of a randomized clinical trial

AIMS: To investigate whether intensive lifestyle intervention induce partial or complete type 2 diabetes (T2D) remission.

MATERIALS AND METHODS: In a secondary analysis of a randomized, assessor-blinded, single-center trial, patients with non-insulin dependent T2D (duration<10 years), were randomly assigned (2:1, stratified by sex, from April 2015 to August 2016) to a lifestyle intervention group (n=64) or a standard care group (n=34). The primary outcome was partial or complete T2D remission defined as non-diabetic glycemia with no glucose-lowering medications at the outcome assessments at both 12- and 24-months from baseline. All participants received standard care with a standardized, blinded, target-driven medical therapy during the initial 12-months. The lifestyle intervention moreover included 5-6 weekly aerobic and combined aerobic and strength training sessions (30-60 min) and individual dietary plans aiming for BMI ≤ 25 kg/m2 . No intervention was provided during the 12 months follow-up period.

RESULTS: Among 98 randomized participants, 93 (mean [SD] age, 54.6 [8.9] years; 46 [43%] women; mean [SD] baseline HbA1c 49.3 [9.3] mmol/mol) completed follow-up. At follow-up, 23%(14) in the intervention and 7%(2) in the standard care group met the criteria for any T2D remission (odds ratio (OR) [95% CI] 4.4 [0.8 to 21.4], p=0.08). Assuming participants lost-to-follow-up (N=5) had relapsed, the OR [95% CI] for T2D remission was 4.4 [1.0 to 19.8] (p=0.048).

CONCLUSIONS: The statistically non-significant three-fold increased remission rate of T2D in the lifestyle intervention group calls for further large-scale studies to understand how to implement sustainable lifestyle interventions in T2D.

STUDY REGISTRATION: ClinicalTrials.gov registration (NCT02417012). This article is protected by copyright. All rights reserved.