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Physical Activity in Youth: Implications for Reversing Risk Factors for Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
SoJung Lee, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00739180
First received: August 20, 2008
Last updated: November 2, 2012
Last verified: October 2012
History of Changes
  Purpose

In this randomized controlled trial, we will examine the effect of a 3-month exercise training (aerobic exercise versus resistance exercise) without calorie restriction on total and regional adiposity, and risk of type 2 diabetes in overweight children and adolescents.


Condition Intervention
Abdominal Obesity
 Other: Control
Other: Resistance Exercise
Other: Aerobic exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Physical Activity in Youth: Implications for Reversing Risk Factors for Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Abdominal obesity, visceral fat [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin sensitivity and secretion, glucose tolerance [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: November 2007
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control
Standard care control
 Other: Control
Standard care control (no exercise)
Active Comparator: Aerobic Exercise Other: Aerobic exercise
Supervised aerobic exercise using treadmills, bikes, and ellipticals
Active Comparator: Resistance Exercise Other: Resistance Exercise
Supervised resistance exercise using stack weight equipments.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy overweight (BMI >-95th) youth between 12 and 18 years of age
  • Waist circumference >-75th percentile
  • Sedentary (no structured exercise >2 times/week for past 6 months)
  • Non-smokers, non-diabetic, no medical conditions
  • Weight stable for past 3 months

Exclusion Criteria:

  • Smokers,
  • diabetic,
  • psychiatric disorders,
  • syndromatic obesity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00739180

Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
American Diabetes Association
Investigators
Principal Investigator: SoJung Lee, PhD University of Pittsburgh
  More Information

No publications provided

Responsible Party: SoJung Lee, Assistant Professor of Pediatrics, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00739180     History of Changes
Other Study ID Numbers: 7-08-JF-27
Study First Received: August 20, 2008
Last Updated: November 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Childhood obesity
Abdominal obesity
Visceral fat
Insulin resistance
 Liver fat
Skeletal muscle lipid
Fitness

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Obesity
Obesity, Abdominal
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013