Beating Diabetes Together: A Randomized Controlled Trial for Intensive Lifestyle Therapy for Youth With Type 2 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Manitoba
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Glycemic control determined by a standard fasting measure of glycosylated hemoglobin using internationally recognized DCCT assay
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 20 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •youth with a BMI considered overweight according to the International Obesity Task Force
- •diagnosed with type 2 diabetes, confirmed with a 2-hour oral glucose tolerance test within two years of enrollment
Exclusion Criteria
- •youth with type 1 diabetes
- •use of insulin or other anti-diabetic drugs
- •youth with medication-induced diabetes
- •youth who have recently been admitted to hospital with ketoacidosis
- •youth have experienced weight loss or enrolled in a weightloss program in the last 6 months
- •youth with an orthapaedic injury preventing them from exercising
- •youth who have a history of alcohol or drug abuse
Outcomes
Primary Outcomes
Glycemic control determined by a standard fasting measure of glycosylated hemoglobin using internationally recognized DCCT assay
Time Frame: 16 weeks
Secondary Outcomes
- Presence of microalbuminuria(16 weeks)
- Anthropometrics(16 weeks)
- Cardiovascular structure and function(16 weeks)
- Cardiometabolic risk Z score(16 weeks)
- Hypertension(16 weeks)
Investigators
Jon McGavock
Assistant Professor
University of Manitoba