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

Introduction: Current 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 analysis: The 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 dissemination: This 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 number: NCT02417012.

Keywords: Diabetes Mellitus, Type 2; Diet; Drug therapy; Exercise; Risk reduction behaviour.

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Figures

Figure 1

Flow of participants through the U-TURN study.

Figure 2

Description of the interventions and co-interventions. Participants are randomised either to intervention (U-TURN) (upper panel) or Standard care (Middle panel). Both groups receive pharmacological treatment and standard diabetes education (Lower panel—in grey). The intervention consists of three phases (1–3). The overall content in phases 1 through 3 is depicted in the green, light blue and light red boxes, respectively. HRR, heart rate reserve; Avg, average per training session.

Figure 3

One electronic inquiry with eight (1–8 in figure) sub-inquiries is administrated to the participants’ intervention (U-TURN) and rated on a daily basis. The participants rate the inquiry from 1 (worst) to 10 (best). If rating is one, the participants are asked for the primary reason. Based on the frequency of the reasons action is taken. The answers are reviewed by the intervention coordination centre on a weekly basis. Based on ratings and frequency of reasons actions (red boxes) are taken.

Figure 4

(A) Illustration of antidiabetic treatment algorithm: Biguanid (tablet Metformin) is initiated at 500 mg once daily up to 1000 mg twice daily. If treatment goal is not reached, then a GLP-1 analogue (injection Victoza) is added at 1.2 mg increasing to 1.8 mg daily. In case of unacceptable adverse effects, a dipeptidyl peptidase inhibitor-4 inhibitor (tablet Januvia) is used at 100 mg daily instead of the GLP-1 analogue. If treatment goal is not reached, then basal insulin (injection Abasaglar) is added (0.2 units/kg once daily). If treatment goal is not reached then meal insulin is added (injection Novorapid titrated based on self-assessed pre-prandial blood glucose measurements in close cooperation with the study nurse). Detailed insulin adjustment is included in the online supplementary material. (B) Illustration of antihypertensive treatment algorithm: An angiotensin II receptor antagonist (tablet Losartan) is initiated at 50 mg daily up to 100 mg daily. If treatment goal is not reached, then a thiazide (tablet Centyl cum KCL) is added at 2.5 mg increasing to 5 mg daily. If treatment goal is not reached, then a calcium antagonist (tablet Amlodipine) is added at 5 mg increasing to 10 mg daily. In case of unacceptable adverse effects, a mineralocorticoid (tablet Spironolactone) is used at 25 mg increasing to 100 mg daily. (C) Illustration of lipid lowering treatment algorithm: A statin (tablet Simvastatin) is initiated at 40 mg daily. If treatment goal is not reached, treatment is replaced by another statin (tablet Atorvastatin) at 10 mg increasing to 40 mg daily.

Figure 5

Forrest plot depicting three scenarios of total sample size from a total of 90 participants (scenario 1), 105 (scenario 2) and 120 participants (scenario 3) with the respective with of 95% CIs. HbA1c, glycated haemoglobin N, number; MD, mean difference.