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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01323088
First received: March 22, 2011
Last updated: April 12, 2013
Last verified: April 2013
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, ectopic fat in the liver and skeletal muscle, and risk of type 2 diabetes in overweight girls.


Condition Intervention
Abdominal Obesity
Physical Activity
 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 Overweight Girls: 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 by a 3-hour hyperinsulinemic-euglycemic clamp, oral glucose tolerance test, liver fat and intramyocellular lipid by 1H-magnetic resonance spectroscopy. [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: August 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control
Standard care control (no-exercise)
 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:   Female
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
  • Diabetes
  • Psychiatric disorders
  • Syndromic obesity
  • Pregnancy
  • Taking medications known to affect study outcomes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01323088

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

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01323088     History of Changes
Other Study ID Numbers: 1R21DK083654-01A1
Study First Received: March 22, 2011
Last Updated: April 12, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on June 18, 2013