Lifestyle Therapy for Youth With Type 2 Diabetes (BDT)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes Mellitus |
Behavioral: Lifestyle Counselling |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Beating Diabetes Together: A Randomized Controlled Trial for Intensive Lifestyle Therapy for Youth With Type 2 Diabetes |
- Glycemic control determined by a standard fasting measure of glycosylated hemoglobin using internationally recognized DCCT assay [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Cardiometabolic risk Z score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]defined as a first morning albumin:creatinine ratio (ACR) 2.5-25 mg/mmol in a first morning urine collection
- Hypertension [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lifestyle counselling
Exercise, nutrition and self-efficacy based lifestyle training in a peer mentoring setting
|
Behavioral: Lifestyle Counselling
Participants will take part in 2-3 group based peer-led sessions per week in which they will learn about healthy lifestyle choices
|
|
No Intervention: Control
Youth randomized to the control group will receive standard care for the first 16 weeks followed by 16 weeks of intervention
|
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| Ages Eligible for Study: | 10 Years to 20 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Jonathon McGavock, PhD | 204-480-1359 | jmcgavock@mich.ca |
| Contact: Angella Griffith, BSc | 204-789-3591 | agriffith@mich.ca |
| Canada, Manitoba | |
| Manitoba Institute of Child Health | Not yet recruiting |
| Winnipeg, Manitoba, Canada, R3E 0P4 | |
| Principal Investigator: Jonathon McGavock, PhD | |
| Principal Investigator: | Jonathon McGavock, PhD | University of Manitoba |
More Information
No publications provided
| Responsible Party: | Jon McGavock, Assistant Professor, University of Manitoba |
| ClinicalTrials.gov Identifier: | NCT01597154 History of Changes |
| Other Study ID Numbers: | B2012:023 |
| Study First Received: | May 9, 2012 |
| Last Updated: | May 10, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of Manitoba:
|
Adolescent Type 2 Diabetes Peer mentorship |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013