Lifestyle and Glucose Lowering Medication in T2DM
This trial is active, not recruiting.
|Condition||diabetes mellitus, type 2|
|Treatments||u-turn, standard care|
|Start date||April 2015|
|End date||September 2017|
|Trial size||97 participants|
|Trial identifier||NCT02417012, U-TURN|
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.
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Change in Hba1c
time frame: 0, 3, 6, 9, 12 months
Change in glucose lowering medication
time frame: 0, 3, 6, 9, 12 months
Male or female participants at least 18 years old.
Inclusion Criteria: - Less than three anti-diabetic medications. - 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: - Hba1c> 9% (75 mmol/mol) - 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
|Official title||Does Intensive Life Style Intervention Reduce the Need for Glucose Lowering Medications in Patients With Type 2 Diabetes? The U-TURN Project|
|Principal investigator||Mathias Ried-Larsen, PhD|
|Description||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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