Type 2 Diabetes Mellitus
Conditions
Keywords
Adolescent, Type 2 Diabetes, Peer mentorship
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.
Interventions
BEHAVIORALLifestyle Counselling
Participants will take part in 2-3 group based peer-led sessions per week in which they will learn about healthy lifestyle choices
Sponsors
Manitoba Institute of Child Health
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 20 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycemic control determined by a standard fasting measure of glycosylated hemoglobin using internationally recognized DCCT assay | 16 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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 |
| 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 |
Countries
Canada
Outcome results
None listed