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

April 12, 2013 updated by: University of Pittsburgh
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Control
Standard care control (no-exercise)
Other: Control
Standard care control (no exercise)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Abdominal obesity, visceral fat
Time Frame: 3 month
3 month

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: SoJung Lee, PhD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

March 22, 2011

First Submitted That Met QC Criteria

March 23, 2011

First Posted (Estimate)

March 25, 2011

Study Record Updates

Last Update Posted (Estimate)

April 15, 2013

Last Update Submitted That Met QC Criteria

April 12, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R21DK083654-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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