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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
  1. Mathias Ried-Larsen1,2,
  2. Robin Christensen3,
  3. Katrine B Hansen1,4,
  4. Mette Y Johansen1,
  5. Maria Pedersen1,
  6. Morten Zacho1,
  7. Louise S Hansen1,
  8. Katja Kofoed1,
  9. Katja Thomsen1,
  10. Mette S Jensen1,
  11. Rasmus O Nielsen1,
  12. Chris MacDonald5,
  13. Henning Langberg1,5,
  14. Allan A Vaag1,4,
  15. Bente K Pedersen1,
  16. Kristian Karstoft1
  1. 1Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark
  2. 2The Danish Diabetes Academy, Odense University Hospital, Odense, Denmark
  3. 3Musculoskeletal Statistics Unit, Department of Rheum, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark
  4. 4Department of Diabetes and Metabolism, Copenhagen University Hospital, Copenhagen, Denmark
  5. 5Department of CopenRehab, Faculty of Health Sciences, Copenhagen University, Copenhagen, Denmark
  1. Correspondence to Dr Mathias Ried-Larsen; mathias.ried-larsen{at}regionh.dk

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.

  • Diabetes Mellitus, Type 2
  • Risk reduction behaviour
  • Exercise
  • Diet
  • Drug therapy

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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