Type 2 Diabetes Mellitus Clinical Trial
Official title:
Beating Diabetes Together: A Randomized Controlled Trial for Intensive Lifestyle Therapy for Youth With Type 2 Diabetes
Background: Little is known about the efficacy of intensive lifestyle therapy (i.e.
increased physical activity and dietary changes) for the management of glycemia and
cardiometabolic risk factors in children and adolescents with type 2 diabetes (T2DM).
Our hypothesis is that education regarding healthy lifestyle changes will significantly
reduce blood sugars in youth with T2DM that do not require insulin therapy. Our secondary
hypothesis is that the intensive lifestyle therapy will cause quick and sustained reductions
in health risk measured by body mass index (BMI), blood pressure, waist circumference, LDL
cholesterol, serum triglycerides and apolipoprotein B.
Youth between the ages of 10-20 years living with type 2 diabetes and not currently on insulin therapy will be randomly assigned to either a lifestyle intervention group or a control group. The lifestyle intervention group will meet 2-3 times per week for 16 weeks to take part in healthy living education sessions involving physical activity, healthy cooking, healthy gardening and how to start and sustain a healthy lifestyle change. At the beginning and end of the 16 weeks the investigators will measure the participants' blood sugars, height, weight, cholesterol, triglycerides and liver enzymes. The investigators will also take a picture of their kidney, heart and blood vessels using ultrasound. Those youth assigned to the control group will receive the 16 week intervention following their 16 week control period. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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