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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01323088
Recruitment Status : Completed
First Posted : March 25, 2011
Last Update Posted : April 15, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Abdominal Obesity Physical Activity Other: Control Other: Resistance Exercise Other: Aerobic exercise

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physical Activity in Overweight Girls: Implications for Reversing Risk Factors for Type 2 Diabetes
Study Start Date : August 2010
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Abdominal obesity, visceral fat [ Time Frame: 3 month ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01323088     History of Changes
Other Study ID Numbers: 1R21DK083654-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 25, 2011    Key Record Dates
Last Update Posted: April 15, 2013
Last Verified: April 2013

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

Additional relevant MeSH terms:
Overweight
Obesity, Abdominal
Body Weight
Signs and Symptoms
Obesity
Overnutrition
Nutrition Disorders