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

This study is currently recruiting participants.

Verified by University of Pittsburgh, October 2008

First Received: August 20, 2008 Last Updated: October 16, 2008 History of Changes

Sponsors and Collaborators:	University of Pittsburgh American Diabetes Association
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00739180

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:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Physical Activity in Youth: Implications for Reversing Risk Factors for Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Exercise and Physical Fitness Obesity Obesity in Children

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 ]

Estimated Enrollment:	48
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Control Standard care control	Other: Control Standard care control (no exercise)
Aerobic Exercise: Active Comparator	Other: Aerobic exercise Supervised aerobic exercise using treadmills, bikes, and ellipticals
Resistance Exercise: Active Comparator	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

Contacts

Contact: SoJung Lee, PHD

412-692-5147

SoJung.Lee@chp.edu

Locations

United States, Pennsylvania
Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: SoJung Lee, PhD SoJung.Lee@chp.edu
Principal Investigator: SoJung Lee, PhD

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:	Children's Hospital of Pittsburgh, University of Pittsburgh ( SoJung Lee/Assistant Professor of Pediatrics )
Study ID Numbers:	7-08-JF-27
Study First Received:	August 20, 2008
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00739180 History of Changes
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

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Insulin
Body Weight
Signs and Symptoms

Diabetes Mellitus, Type 2
Nutrition Disorders
Overnutrition
Endocrinopathy
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus

Nutrition Disorders
Endocrine System Diseases
Overweight
Overnutrition
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 11, 2009