Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
97 participants
INTERVENTIONAL
2015-04-30
2017-09-30
Brief Summary
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Detailed Description
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The primary hypothesis is that lifestyle change is equivalent in maintaining glycemic control (Hba1c) compared to the standard pharmacological treatment,
The U-TURN trial also tests the effects on one key secondary outcome (glucose lowering medication) and examines the effects on sleep quality, fatigue sleepiness, sleep pattern, cardio vascular disease risk factors, psychological outcomes, blood pressure and cholesterol lowering medication. The participants (N=120) is randomized into a experimental group (N=80) and a standard care group (N=40).
Additionally, the effects of the study will be evaluated 24 month post randomization.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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U-TURN intervention
The intervention group will receive an intensive lifestyle intervention including partly supervised aerobic and strength exercise, diet plans and counseling by clinical dietitians. All exercise will be supervised initially and the supervision will be reduced gradually across the 12-month intervention. Additionally, the participants will be offered educational classes on implementation of a healthy lifestyle and diabetes education and support by trained nurses.
Participants in this group will have their pharmacological treatment regulated by the study endocrinologists using a standardized pharmacological treatment. The treatment is in accordance with the Danish guidelines.
U-TURN
Participants in this group will receive individual and group based interventions on obtaining and maintaining a healthy lifestyle, while having the pharmacological treatment regulated
Standard care
The reference group will receive diabetes education and support by trained nurses.
Participants in this group will have their pharmacological treatment regulated by the study endocrinologists using a standardized pharmacological treatment. The treatment is in accordance with the Danish guidelines.
Standard care
Standard individual diabetes support
Interventions
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U-TURN
Participants in this group will receive individual and group based interventions on obtaining and maintaining a healthy lifestyle, while having the pharmacological treatment regulated
Standard care
Standard individual diabetes support
Eligibility Criteria
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Inclusion Criteria
* Diabetes 2 duration of max 10 years
* BMI \>25 but \<40 kg/m2,
* Accept of medical regulation by the UTURN endocrinologists only
* Accept of purchasing a fitness club membership through U-TURN collaborator
Exclusion Criteria
* Insulin usage
* Presence of one or more of the following micro- and macrovascular complications of T2DM; a.Diabetic retinopathy (except mild nonproliferative retinopathy or early proliferative retinopathy) b. Macro-albuminuria or nephropathy c. Diabetic neuropathy (except mild affected vibratory testing (\<50 Volt)) d. Arterial insufficiency e. Ischemic heart disease
* Steroid treatment (inhalation) until three months before the medical examination
* TSH raised/below the normal range
* Liver disease (ALAT/ASAT thrice normal range)
* Inability or contraindication to increased levels of physical activity (Pedersen BK and Saltin B)
* Evidence of anaemia
* Lung disease (except mild asthma and mild chronic obstructive pulmonary disease)
* Heart disease
* Kidney disease (creatinine above 130 µM or macro albuminuria)
* Pregnancy
18 Years
ALL
No
Sponsors
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TRYG Foundation
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
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Mathias Ried-Larsen
Group leader
Principal Investigators
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Mathias Ried-Larsen, PhD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Center for Physical Activity Research, Copenhagen University Hospital
Copenhagen, , Denmark
Countries
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References
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Pedersen BK, Saltin B. Evidence for prescribing exercise as therapy in chronic disease. Scand J Med Sci Sports. 2006 Feb;16 Suppl 1:3-63. doi: 10.1111/j.1600-0838.2006.00520.x.
Legaard GE, Feineis CS, Johansen MY, Hansen KB, Vaag AA, Larsen EL, Poulsen HE, Almdal TP, Karstoft K, Pedersen BK, Ried-Larsen M. Effects of an exercise-based lifestyle intervention on systemic markers of oxidative stress and advanced glycation endproducts in persons with type 2 diabetes: Secondary analysis of a randomised clinical trial. Free Radic Biol Med. 2022 Aug 1;188:328-336. doi: 10.1016/j.freeradbiomed.2022.06.013. Epub 2022 Jun 25.
Abildgaard J, Johansen MY, Skov-Jeppesen K, Andersen LB, Karstoft K, Hansen KB, Hartmann B, Holst JJ, Pedersen BK, Ried-Larsen M. Effects of a Lifestyle Intervention on Bone Turnover in Persons with Type 2 Diabetes: A Post Hoc Analysis of the U-TURN Trial. Med Sci Sports Exerc. 2022 Jan 1;54(1):38-46. doi: 10.1249/MSS.0000000000002776.
MacDonald CS, Nielsen SM, Bjorner J, Johansen MY, Christensen R, Vaag A, Lieberman DE, Pedersen BK, Langberg H, Ried-Larsen M, Midtgaard J. One-year intensive lifestyle intervention and improvements in health-related quality of life and mental health in persons with type 2 diabetes: a secondary analysis of the U-TURN randomized controlled trial. BMJ Open Diabetes Res Care. 2021 Jan;9(1):e001840. doi: 10.1136/bmjdrc-2020-001840.
Johansen MY, Karstoft K, MacDonald CS, Hansen KB, Ellingsgaard H, Hartmann B, Wewer Albrechtsen NJ, Vaag AA, Holst JJ, Pedersen BK, Ried-Larsen M. Effects of an intensive lifestyle intervention on the underlying mechanisms of improved glycaemic control in individuals with type 2 diabetes: a secondary analysis of a randomised clinical trial. Diabetologia. 2020 Nov;63(11):2410-2422. doi: 10.1007/s00125-020-05249-7. Epub 2020 Aug 20.
MacDonald CS, Johansen MY, Nielsen SM, Christensen R, Hansen KB, Langberg H, Vaag AA, Karstoft K, Lieberman DE, Pedersen BK, Ried-Larsen M. Dose-Response Effects of Exercise on Glucose-Lowering Medications for Type 2 Diabetes: A Secondary Analysis of a Randomized Clinical Trial. Mayo Clin Proc. 2020 Mar;95(3):488-503. doi: 10.1016/j.mayocp.2019.09.005. Epub 2020 Jan 30.
Johansen MY, MacDonald CS, Hansen KB, Karstoft K, Christensen R, Pedersen M, Hansen LS, Zacho M, Wedell-Neergaard AS, Nielsen ST, Iepsen UW, Langberg H, Vaag AA, Pedersen BK, Ried-Larsen M. Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA. 2017 Aug 15;318(7):637-646. doi: 10.1001/jama.2017.10169.
Ried-Larsen M, Christensen R, Hansen KB, Johansen MY, Pedersen M, Zacho M, Hansen LS, Kofoed K, Thomsen K, Jensen MS, Nielsen RO, MacDonald C, Langberg H, Vaag AA, Pedersen BK, Karstoft K. 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. BMJ Open. 2015 Dec 9;5(12):e009764. doi: 10.1136/bmjopen-2015-009764.
Other Identifiers
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U-TURN
Identifier Type: -
Identifier Source: org_study_id