Lifestyle Therapy for Youth With Type 2 Diabetes

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Behavioral: Lifestyle Counselling

• Registration Number: NCT01597154
• Lead Sponsor: University of Manitoba

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 Timeline

• Study First Submitted: 2012-05-09
• Study First Submitted QC: 2012-05-10
• Study First Posted: 2012-05-11
• Study Start: 2012-09
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-28
• Last Update Posted: 2014-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle counselling	Lifestyle Counselling	Exercise, nutrition and self-efficacy based lifestyle training in a peer mentoring setting

Primary Outcome Measures

Name	Time	Method
Glycemic control determined by a standard fasting measure of glycosylated hemoglobin using internationally recognized DCCT assay	16 weeks

Secondary Outcome Measures

Name	Time	Method
Presence of microalbuminuria	16 weeks	defined as a first morning albumin:creatinine ratio (ACR) 2.5-25 mg/mmol in a first morning urine collection
Anthropometrics	16 weeks	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
Cardiovascular structure and function	16 weeks	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
Cardiometabolic risk Z score	16 weeks	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)
Hypertension	16 weeks	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

Trial Locations

Locations (1)

Manitoba Institute of Child Health; 🇨🇦 Winnipeg, Manitoba, Canada