Lifestyle and Glucose Lowering Medication in T2DM

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Does Intensive Life Style Intervention Reduce the Need for Glucose Lowering Medications in Patients With Type 2 Diabetes? The U-TURN Project

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: U-TURN
* Behavioral: Standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: U-TURN intervention<br>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. | Behavioral: U-TURN<br>* Participants in this group will receive individual and group based interventions on obtaining and maintaining a healthy lifestyle, while having the pharmacological treatment regulated<br>|
| Active Comparator: Standard care<br>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. | Behavioral: Standard care<br>* Standard individual diabetes support<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hba1c | blood sampling of Hba1c | 0, 3, 6, 9, 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lifestyle, exercise, physical activity, diet, glycemic control, hba1c, glucose lowering drugs