Lifestyle Therapy for Youth With Type 2 Diabetes (BDT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01597154
Recruitment Status : Completed
First Posted : May 11, 2012
Last Update Posted : July 29, 2014
Manitoba Institute of Child Health
Information provided by (Responsible Party):
Jon McGavock, 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: Lifestyle Counselling Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Beating Diabetes Together: A Randomized Controlled Trial for Intensive Lifestyle Therapy for Youth With Type 2 Diabetes
Study Start Date : September 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Glycemic control determined by a standard fasting measure of glycosylated hemoglobin using internationally recognized DCCT assay [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Cardiometabolic risk Z score [ Time Frame: 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)

  2. Presence of microalbuminuria [ Time Frame: 16 weeks ]
    defined as a first morning albumin:creatinine ratio (ACR) 2.5-25 mg/mmol in a first morning urine collection

  3. Hypertension [ Time Frame: 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

  4. Anthropometrics [ Time Frame: 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

  5. Cardiovascular structure and function [ Time Frame: 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

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Ages Eligible for Study:   10 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01597154

Canada, Manitoba
Manitoba Institute of Child Health
Winnipeg, Manitoba, Canada, R3E 0P4
Sponsors and Collaborators
University of Manitoba
Manitoba Institute of Child Health
Principal Investigator: Jonathon McGavock, PhD University of Manitoba

Responsible Party: Jon McGavock, Assistant Professor, University of Manitoba Identifier: NCT01597154     History of Changes
Other Study ID Numbers: B2012:023
First Posted: May 11, 2012    Key Record Dates
Last Update Posted: July 29, 2014
Last Verified: July 2014

Keywords provided by Jon McGavock, University of Manitoba:
Type 2 Diabetes
Peer mentorship

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases