Lifestyle Therapy for Youth With Type 2 Diabetes (BDT)

This study has been completed.
Sponsor:
Collaborator:
Manitoba Institute of Child Health
Information provided by (Responsible Party):
Jon McGavock, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01597154
First received: May 9, 2012
Last updated: July 28, 2014
Last verified: July 2014
  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

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Enrollment: 15
Study Start Date: September 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597154

Locations
Canada, Manitoba
Manitoba Institute of Child Health
Winnipeg, Manitoba, Canada, R3E 0P4
Sponsors and Collaborators
University of Manitoba
Manitoba Institute of Child Health
Investigators
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: July 28, 2014
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014