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Completed

NCT Number: NCT01597154

Lifestyle Therapy for Youth With Type 2 Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manitoba Institute of Child Health

Winnipeg, Manitoba, R3E 0P4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: 16 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Manitoba Institute of Child Health

Registry information

Official study title

Beating Diabetes Together: A Randomized Controlled Trial for Intensive Lifestyle Therapy for Youth With Type 2 Diabetes

Acronym: BDT

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 11, 2012
Registry last updated
Jul 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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