Head-to-head comparison of intensive lifestyle intervention (U-TURN) versus conventional multifactorial care in patients with type 2 diabetes: protocol and rationale for an assessor-blinded, parallel group and randomised trial

Abstract

IntroductionCurrent pharmacological therapies in patients with type 2 diabetes (T2D) are challenged by lack of sustainability and borderline firm evidence of real long-term health benefits. Accordingly, lifestyle intervention remains the corner stone in the management of T2D. However, there is a lack of knowledge regarding the optimal intervention programmes in T2D ensuring both compliance as well as long-term health outcomes. Our objective is to assess the effects of an intensive lifestyle intervention (the U-TURN intervention) on glycaemic control in patients with T2D. Our hypothesis is that intensive lifestyle changes are equally effective as standard diabetes care, including pharmacological treatment in maintaining glycaemic control (ie, glycated haemoglobin (HbA1c)) in patients with T2D. Furthermore, we expect that intensive lifestyle changes will decrease the need for antidiabetic medications.Methods and analysisThe study is an assessor-blinded, parallel group and a 1-year randomised trial. The primary outcome is change in glycaemic control (HbA1c), with the key secondary outcome being reductions in antidiabetic medication. Participants will be patients with T2D (T2D duration <10 years) without complications who are randomised into an intensive lifestyle intervention (U-TURN) or a standard care intervention in a 2:1 fashion. Both groups will be exposed to the same standardised, blinded, target-driven pharmacological treatment and can thus maintain, increase, reduce or discontinue the pharmacological treatment. The decision is based on the standardised algorithm. The U-TURN intervention consists of increased training and basal physical activity level, and an antidiabetic diet including an intended weight loss. The standard care group as well as the U-TURN group is offered individual diabetes management counselling on top of the pharmacological treatment.Ethics and disseminationThis study has been approved by the Scientific Ethical Committee at the Capital Region of Denmark (H-1–2014–114). Positive, negative or inconclusive findings will be disseminated in peer-reviewed journals, at national and international conferences.Trial registration numberNCT02417012.

Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes

“…The secondary outcome (reduction in glucoselowering medication) was reported as the between-group difference in the proportion of the participants (risk difference, percentage point), who reduced their need for glucoselowering medication according to the prespecified algorithm from baseline to 12-month follow-up. 13 A reduction from baseline was scored as 0 (no reduction) or 1 (a reduction). Additionally, we explored the between-group difference in the proportion of participants, who completely discontinued their blinded, target-driven, glucose-lowering medical therapy from baseline to 12-month follow-up as well as the difference in the proportion of participants who increased their treatment from baseline to 12-month follow-up according to the same prespecified algorithm.…”

“…At least 6 weeks prior to baseline measurements, all participants had their glucose-lowering, lipidlowering, and blood pressure-lowering medications titrated by the study endocrinologist to obtain prespecified treatment targets. 13 Response to the medical standardization did not constitute reason for exclusion. Medical standardization was performed to assess the effect of the lifestyle intervention without amplifying the result due to poorly regulated HbA 1c levels at baseline.…”

“…If HbA 1c level exceeded 7.5%, the glucose-lowering medication was increased according to the prespecified algorithm. 13 The lifestyle participants additionally received an intensive lifestyle intervention, described in detail previously, 13 which consisted of 5 to 6 weekly aerobic sessions (duration 30-60 minutes), of which 2 to 3 sessions were combined with resistance training. For the first 4 months, all exercise sessions were supervised, and supervision was progressively reduced during the 12 months.…”

“…The sample size was truncated based on a formal stop rule defined as 24 months (August 2015) prior to the study end date of the preplanned 24-month follow-up (August 2017). 13 …”

Type 2 diabetes remission 1 year after an intensive lifestyle intervention: A secondary analysis of a randomized clinical trial

“…The present extension study was designed as a pragmatic superiority study based on follow‐up assessment of the participants in a recent single‐centre clinical trial (Appendix S1), conducted in the Capital Region of Denmark from 29 April 2015 to 17 August 2017 and including 98 participants. The primary outcome was assessed after a 12‐month intervention and published previously .…”