Lifestyle Therapy for Youth With Type 2 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Beating Diabetes Together: A Randomized Controlled Trial for Intensive Lifestyle Therapy for Youth With Type 2 Diabetes

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Lifestyle Counselling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counselling<br>Exercise, nutrition and self-efficacy based lifestyle training in a peer mentoring setting | Behavioral: Lifestyle Counselling<br>* Participants will take part in 2-3 group based peer-led sessions per week in which they will learn about healthy lifestyle choices<br>|
| No Intervention: Control<br>Youth randomized to the control group will receive standard care for the first 16 weeks followed by 16 weeks of intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control determined by a standard fasting measure of glycosylated hemoglobin using internationally recognized DCCT assay |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiometabolic risk Z score | This is a composite score based on BMI z-score, waist circumference, c-reactive protein (CRP), fibrinogen, low density lipoprotein (LDL) and high density lipoprotein (HDL) cholesterol, triglycerides (TG) and apolipoprotein B (apoB), and a marker of fatty liver disease, alanine transaminase (ALT) | 16 weeks | 
| Presence of microalbuminuria | defined as a first morning albumin:creatinine ratio (ACR) 2.5-25 mg/mmol in a first morning urine collection | 16 weeks | 
| Hypertension | defined as a systolic blood pressure load >25% or a mean 24 hour systolic blood pressure >95th %ile for sex and height on 24 hour ambulatory blood pressure monitoring | 16 weeks | 
| Anthropometrics | Waist circumference in centimeters, body mass index (BMI) z-score and percent body fat will be assessed to determine if changes in body composition are associated with improvements in cardiometabolic risk | 16 weeks | 
| Cardiovascular structure and function | Vascular health will be assessed with non-invasive assessments of arterial stiffness, endothelium-dependant relaxation and carotid intima media thickness which will be treated as continuous variables. Left ventricular structure and function will be assessed using standard M-mode and doppler ultrasound techniques | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent, Type 2 Diabetes, Peer mentorship