Lifestyle Therapy for Youth With Type 2 Diabetes

NCT01597154 | Completed

• 1 other identifier: B2012:023
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Adolescent; Type 2 Diabetes; Peer mentorship

Outcome Measures

Primary Outcomes (1)

• Glycemic control determined by a standard fasting measure of glycosylated hemoglobin using internationally recognized DCCT assay

  16 weeks

Secondary Outcomes (5)

• Cardiometabolic risk Z score

  16 weeks

• Presence of microalbuminuria

  16 weeks

• Hypertension

  16 weeks

• Anthropometrics

  16 weeks

• Cardiovascular structure and function

  16 weeks

Study Arms (2)

Lifestyle counselling

EXPERIMENTAL

Exercise, nutrition and self-efficacy based lifestyle training in a peer mentoring setting

Behavioral: Lifestyle Counselling

Control

NO INTERVENTION

Youth randomized to the control group will receive standard care for the first 16 weeks followed by 16 weeks of intervention

Interventions

Lifestyle Counselling BEHAVIORAL

Participants will take part in 2-3 group based peer-led sessions per week in which they will learn about healthy lifestyle choices

Lifestyle counselling

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• Manitoba Institute of Child Health: collaborator

Study Sites (1)

Manitoba Institute of Child Health

Winnipeg, Manitoba, R3E 0P4, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jonathon McGavock, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 9, 2012
• First Posted: May 11, 2012
• Study Start: September 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 29, 2014

Record last verified: 2014-07

Locations

CA (1)