A Study of the Effects of Exercise Intensity on Insulin Sensitivity in Overweight Youth

NCT00755547 | Completed Phase 4

• 2 other identifiers: SC-5-08-2489-JMGRT2008-10
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The investigators know that exercise helps children develop strong bones and muscles and generally stay healthy. What is unclear however, is how much exercise a child needs to lower their risk of developing type 2 diabetes. Objective: The investigators will try to find out whether high-intensity exercise for a short-period of time is better than moderately intense exercise for improving the diabetes risk profile in teens who are at risk for type 2 diabetes. The working hypothesis is that exercise-mediated improvements in insulin sensitivity (a risk factor for diabetes) will be greater following vigorous intermittent physical activity than following low intensity physical activity in overweight adolescents 13-18 yrs at risk for T2DM. Brief Description of Research Project: Teenagers between the ages of 13 and 18 yrs, who are at risk for type 2 diabetes (either by their family history or an abnormal response to sugar) will be randomly assigned to one of two activity groups or a control group. The activity groups will have supervised exercise sessions 3 to 5 days per week for 6 months. One group will do high-intensity exercise, and the other will do lower-intensity exercise. We will measure how sensitive their body is to insulin and the amount of fat in their muscle and liver tissue at the beginning and end of the exercise intervention.

Conditions

Type 2 Diabetes Mellitus; Adolescent Obesity

Keywords

Childhood; insulin sensitivity; steatosis, spectroscopy

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity measured from Bergman's frequently sampled intravenous glucose tolerance test

  6 months

Secondary Outcomes (1)

• 1H-Magnetic resonance spectroscopy-derived measure of lipid content in liver and muscle tissue

  6 months

Study Arms (3)

High Intensity

EXPERIMENTAL

70-85% of peak oxygen uptake for 30 min 3-5 days/week.

Other: Aerobic Exercise Training

Low Intensity

EXPERIMENTAL

40-55% of peak oxygen uptake for 60 min 3-5 days/week

Other: Aerobic Exercise Training

Sedentary Control

NO INTERVENTION

Regular activities of daily living for 6 months

Interventions

Aerobic Exercise Training OTHER

All sessions will be designed to elicit a certain degree of energy expenditure that will progressively increase throughout the trial. Adolescents randomized to the vigorous activity group will perform interval sessions that ensure an average heart rate between 70 and 85% of maximal heart rate reserve while those randomized will perform aerobic activity between 40 and 50% of heart rate reserve. The goal for the trial will be to expend a minimum of 350 kcal. The type of exercise will depend on the preference of each participant however, during the supervised sessions walking/jogging on a treadmill or outdoors will be used to elicit exercise intensities. The three activity sessions held at the YMCA-YWCA facilities in Winnipeg and be supervised by a trained kinesiologist who will record heart rate and perceived exertion for each session.

High Intensity; Low Intensity

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ethnic minority considered at risk for T2DM
• In utero exposure to hyperglycemia (i.e. mother with gestational or frank diabetes during pregnancy) and/or evidence of hepatic steatosis (serum ALT \> 60U/L, ultrasound or MRI-based evidence of steatosis).

You may not qualify if:

• The investigators will exclude any patients that may have altered insulin sensitivity or tissue lipid content that would confound (mask) the effects of the intervention.
• These include overweight adolescents who:
• are diagnosed with impaired glucose tolerance or type 2 diabetes
• are currently being treated with corticosteroids or atypical antipsychotics, as these agents significantly influence carbohydrate metabolism
• are undergoing puberty (Tanner Stage 2-4) at the time of the investigation, as it is associated with transient changes in insulin sensitivity
• have an orthopaedic injury that would prevent them from performing the intervention
• have experienced weight loss or enrolled in weight loss program in the six months prior to the study
• have a history of alcoholism 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, R3E3P4, Canada

Location

Related Publications (2)

• Hrubeniuk TJ, Hay JL, MacIntosh AC, Wicklow B, Wittmeier K, McGavock JM, Senechal M. Interindividual variation in cardiometabolic health outcomes following 6 months of endurance training in youth at risk of type 2 diabetes mellitus. Appl Physiol Nutr Metab. 2021 Jul;46(7):727-734. doi: 10.1139/apnm-2020-0707. Epub 2021 Feb 5.

  PMID: 33544653 DERIVED

• Mollard RC, Senechal M, MacIntosh AC, Hay J, Wicklow BA, Wittmeier KD, Sellers EA, Dean HJ, Ryner L, Berard L, McGavock JM. Dietary determinants of hepatic steatosis and visceral adiposity in overweight and obese youth at risk of type 2 diabetes. Am J Clin Nutr. 2014 Apr;99(4):804-12. doi: 10.3945/ajcn.113.079277. Epub 2014 Feb 12.

  PMID: 24522441 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Pediatric Obesity; Insulin Resistance; Fatty Liver

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Liver Diseases; Digestive System Diseases

Study Officials

• Jonathan M McGavock, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 18, 2008
• First Posted: September 19, 2008
• Study Start: April 1, 2008
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 29, 2013

Record last verified: 2013-03

Locations

CA (1)