Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Does Intensive Life Style Intervention Reduce the Need for Glucose Lowering Medications in Patients With Type 2 Diabetes? The U-TURN Project
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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