title: 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: BACKGROUND
  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
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  NCT02417012.
authors.affiliation: Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark The Danish Diabetes Academy, Odense University Hospital, Odense, Denmark.
authors.forename: Mathias
authors.initials: M
authors.lastname: Ried-Larsen
authors.affiliation: Musculoskeletal Statistics Unit, Department of Rheum, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
authors.forename: Robin
authors.identifier: http://orcid.org/0000-0002-6600-0631
authors.initials: R
authors.lastname: Christensen
authors.affiliation: Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark Department of Diabetes and Metabolism, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Katrine B
authors.initials: KB
authors.lastname: Hansen
authors.affiliation: Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Mette Y
authors.initials: MY
authors.lastname: Johansen
authors.affiliation: Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Maria
authors.initials: M
authors.lastname: Pedersen
authors.affiliation: Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Morten
authors.initials: M
authors.lastname: Zacho
authors.affiliation: Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Louise S
authors.initials: LS
authors.lastname: Hansen
authors.affiliation: Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Katja
authors.initials: K
authors.lastname: Kofoed
authors.affiliation: Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Katja
authors.initials: K
authors.lastname: Thomsen
authors.affiliation: Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Mette S
authors.initials: MS
authors.lastname: Jensen
authors.affiliation: Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Rasmus O
authors.initials: RO
authors.lastname: Nielsen
authors.affiliation: Department of CopenRehab, Faculty of Health Sciences, Copenhagen University, Copenhagen, Denmark.
authors.forename: Chris
authors.initials: C
authors.lastname: MacDonald
authors.affiliation: Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark Department of CopenRehab, Faculty of Health Sciences, Copenhagen University, Copenhagen, Denmark.
authors.forename: Henning
authors.initials: H
authors.lastname: Langberg
authors.affiliation: Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark Department of Diabetes and Metabolism, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Allan A
authors.initials: AA
authors.lastname: Vaag
authors.affiliation: Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Bente K
authors.initials: BK
authors.lastname: Pedersen
authors.affiliation: Center for Physical Activity Research, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Kristian
authors.initials: K
authors.lastname: Karstoft
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000032:analysis; D003718:Denmark; D003924:Diabetes Mellitus, Type 2 / Q000628:therapy*; D004032:Diet; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D008019:Life Style; D008297:Male; D008875:Middle Aged; D009043:Motor Activity; D010353:Patient Education as Topic / Q000379:methods*; D012107:Research Design; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents
keywords: Diabetes Mellitus, Type 2; Diet; Drug therapy; Exercise; Risk reduction behaviour