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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.
Ried-Larsen, Mathias; Christensen, Robin; Hansen, Katrine B; Johansen, Mette Y; Pedersen, Maria; Zacho, Morten; Hansen, Louise S; Kofoed, Katja; Thomsen, Katja; Jensen, Mette S; Nielsen, Rasmus O; MacDonald, Chris; Langberg, Henning; Vaag, Allan A; Pedersen, Bente K; Karstoft, Kristian.
Afiliación
  • Ried-Larsen M; Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark The Danish Diabetes Academy, Odense University Hospital, Odense, Denmark.
  • Christensen R; Musculoskeletal Statistics Unit, Department of Rheum, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
  • Hansen KB; Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark Department of Diabetes and Metabolism, Copenhagen University Hospital, Copenhagen, Denmark.
  • Johansen MY; Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark.
  • Pedersen M; Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark.
  • Zacho M; Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark.
  • Hansen LS; Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark.
  • Kofoed K; Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark.
  • Thomsen K; Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark.
  • Jensen MS; Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark.
  • Nielsen RO; Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark.
  • MacDonald C; Department of CopenRehab, Faculty of Health Sciences, Copenhagen University, Copenhagen, Denmark.
  • Langberg H; Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark Department of CopenRehab, Faculty of Health Sciences, Copenhagen University, Copenhagen, Denmark.
  • Vaag AA; Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark Department of Diabetes and Metabolism, Copenhagen University Hospital, Copenhagen, Denmark.
  • Pedersen BK; Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark.
  • Karstoft K; Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark.
BMJ Open ; 5(12): e009764, 2015 Dec 09.
Article en En | MEDLINE | ID: mdl-26656025
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Proyectos de Investigación / Educación del Paciente como Asunto / Diabetes Mellitus Tipo 2 / Estilo de Vida Tipo de estudio: Clinical_trials / Prognostic_studies Aspecto: Ethics Límite: Adolescent / Adult / Aged / Aged80 / Female / Humans / Male / Middle aged País/Región como asunto: Europa Idioma: En Revista: BMJ Open Año: 2015 Tipo del documento: Article País de afiliación: Dinamarca Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Proyectos de Investigación / Educación del Paciente como Asunto / Diabetes Mellitus Tipo 2 / Estilo de Vida Tipo de estudio: Clinical_trials / Prognostic_studies Aspecto: Ethics Límite: Adolescent / Adult / Aged / Aged80 / Female / Humans / Male / Middle aged País/Región como asunto: Europa Idioma: En Revista: BMJ Open Año: 2015 Tipo del documento: Article País de afiliación: Dinamarca Pais de publicación: Reino Unido