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| Name | Class |
|---|---|
| TRYG Foundation | OTHER |
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This study evaluates the effect of a lifestyle intervention maintenance of glycemic control while reducing glucose lowering drugs in patients with type 2 diabetes mellitus. The intervention group receives an intensive lifestyle intervention including exercise and diet lifestyle modifications. The reference group receives diabetes educational advice. Both groups will have their pharmacological treatment regulated across the study. The primary hypothesis is that lifestyle change is sufficient to maintain glycemic control while decreasing the anti-diabetic medication in a sample patients with type 2 diabetes mellitus.
Adherence to lifestyle modifications including increased exercise and healthy diet improves glycemic control in patients with type 2 diabetes mellitus. However, few have investigated the combined effects of these lifestyle changes on maintenance of glycemic control while decreasing the usage of anti-diabetic medications.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| U-TURN intervention | Experimental | 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. |
|
| Standard care | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| U-TURN | Behavioral | Participants in this group will receive individual and group based interventions on obtaining and maintaining a healthy lifestyle, while having the pharmacological treatment regulated |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hba1c | blood sampling of Hba1c | 0, 3, 6, 9, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glucose lowering medication | Change in doses of Metformin, GLP-1 analog, insulin. The change will be evaluate according to changes on the pre-specified regulation algorithm. | 0, 3, 6, 9, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of hypo-glycemic episodes | Self-report to study nurse | 0, 3, 6, 9, 12, 24 months |
| Changes Ldl cholesterol | Blod sampling | 0, 3, 6, 9, 12, 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mathias Ried-Larsen, PhD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Physical Activity Research, Copenhagen University Hospital | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16451303 | Background | 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. | |
| 35764194 | Derived | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard care | Behavioral | Standard individual diabetes support |
|
| Changes Hdl cholesterol | Blood sampling | 0, 3, 6, 9, 12, 24 months |
| Changes total cholesterol | Blood sampling | 0, 3, 6, 9, 12, 24 months |
| Changes in triglycerides | Blood sampling | 0, 3, 6, 9, 12, 24 months |
| Changes in bdnf-a | Blood sampling | 0, 12 months |
| Change in physical fitness | Progressive treadmill protocol | 0, 12, 24 months |
| Change in body composition (DXA scan) | DXA scan | 0, 3, 6, 9, 12, 24 months |
| Change in sleep quality | Self-report using the PSQI questionnaire | 0, 12, months |
| Change in sleepiness | Self-report using the Epsworth questionnaire | 0, 12, months |
| Change in sleep pattern | Cardio-respiratory monitoring | 0, 12, months |
| Change in the degree of depression | Self-report using the BDI-II questionnaire | 0, 12, 24 months |
| Change in Glucose tolerance (2-h oral glucose tolerance test) | 2-h oral glucose tolerance test | 0, 12, 24 months |
| Change in Well-being | Self-report using the questionnaire SF-36 and MFI20 | 0, 12, 24 months |
| Change in motivation for exercise | Self-report using the questionnaire BREQ-2 | 0, 12, 24 months |
| Change in cognitive function | Self-report using the CANTAB test battery | 0, 12 months |
| Change in arterial function | Arterial function will be determined using flow mediated dilation in a sub set of N=20 patients in each intervention arm (Total N=20) | 0, 12 months |
| Partial T2D remission | No active glucose lowering medication and HbA1c<48 mmol/mol and Fasting blood glucose<6,9 mmol/l | 24 months |
| Full T2D remission | No active glucose lowering medication and HbA1c<39 mmol/mol and Fasting blood glucose<5.6 mmol/l | 24 months |
| Change in low grade inflammation | The change in pro- and anti inflammatory markers will be evaluated | 0, 12, 24 months |
| 34431828 | Derived | 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. |
| 33441418 | Derived | 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. |
| 32816096 | Derived | 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. |
| 32007295 | Derived | 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. |
| 28810024 | Derived | 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. |
| 26656025 | Derived | 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. |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |