Clinical trial NCT01597154: Lifestyle Therapy for Youth With Type 2 Diabetes
Official title: Beating Diabetes Together: A Randomized Controlled Trial for Intensive Lifestyle Therapy for Youth With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Adolescent
Type 2 Diabetes
Peer mentorship
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Manitoba Institute of Child Health
First posted: 2012-05-11
Enrollment: 15
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycemic control determined by a standard fasting measure of glycosylated hemoglobin using internationally recognized DCCT assay
timeFrame: 16 weeks
Secondary outcomes:
measure: Cardiometabolic risk Z score
timeFrame: 16 weeks
measure: Presence of microalbuminuria
timeFrame: 16 weeks
measure: Hypertension
timeFrame: 16 weeks
measure: Anthropometrics
timeFrame: 16 weeks
measure: Cardiovascular structure and function
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Manitoba Institute of Child Health
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Jonathon McGavock, PhD
role: PRINCIPAL_INVESTIGATOR
References: