Six-year follow-up of glycemic control and cardiovascular risk factors after a one-year intensive lifestyle intervention in type 2 diabetes: An extension of the randomized U-TURN trial.

PURPOSE This study aimed to describe the effects of a 1-year lifestyle intervention on hemoglobin A1c (HbA1c) and cardiovascular risk factors 5 years after cessation of the lifestyle intervention in persons with type 2 diabetes (T2D). METHODS From April 2015 to August 2016, 98 persons with T2D (duration < 10 years) were randomly allocated (2:1, stratified by sex) to a 1-year lifestyle intervention group (INT) (n = 64) or a standard care group (StC) (n = 34). All participants received standard care with blinded, target-driven medical therapy. INT included up to 5-6 weekly supervised aerobic and strength training sessions and dietary plans targeting a body mass index ≤ 25 kg/m². No intervention was given during the follow-up period. Forty-nine (77%) and 19 (56%) participants in INT and StC attended the 6-year follow-up. Based on the original intention-to-treat population, the primary outcome was the change in HbA1c from baseline to 6-year follow-up. Secondary outcomes included weight, Low density lipoprotein (LDL) cholesterol, blood pressure (BP), and cardiorespiratory fitness. RESULTS Ninety-eight participants (mean age 54.6 years; 46% women; mean baseline Hemoglobin A1c (HbA1c): 49.8 mmol/mol) were analyzed. HbA1c changed 6% and 13% in the INT and StC from baseline to 6-year follow-up (between group difference: -6% (95%CI: -14 to 3); p = 0.18). While no differences were observed for most secondary outcomes, the diastolic BP decreased 6.0 (95%CI: 2.1 to 9.8) mmHg more in the StC compared to INT. CONCLUSION The sustained effect of the lifestyle intervention on glycemic control and cardiovascular risk factors was marginal, and it was surprisingly associated with inferior diastolic BP regulation.