- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00739180
Physical Activity in Youth: Implications for Reversing Risk Factors for Type 2 Diabetes
November 2, 2012 updated by: SoJung Lee, 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, and risk of type 2 diabetes in overweight children and adolescents.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
45
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
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- 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
Male
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,
- diabetic,
- psychiatric disorders,
- syndromatic obesity
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 |
---|---|
Other: Control
Standard care control
|
Standard care control (no exercise)
|
Active Comparator: Aerobic Exercise
|
Supervised aerobic exercise using treadmills, bikes, and ellipticals
|
Active Comparator: Resistance Exercise
|
Supervised resistance exercise using stack weight equipments.
|
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 and secretion, glucose tolerance
Time Frame: 3 month
|
3 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
- Yu WW, Lee S, Arslanian S, Tamim H, Kuk JL. Effects of Exercise on Resting Metabolic Rate in Adolescents with Overweight and Obesity. Child Obes. 2021 Jun;17(4):249-256. doi: 10.1089/chi.2020.0280. Epub 2021 Mar 18.
- Kuk JL, Lee S. Assessing the utility of cardiorespiratory fitness, visceral fat, and liver fat in predicting changes in insulin sensitivity beyond simple changes in body weight after exercise training in adolescents. Appl Physiol Nutr Metab. 2021 Jan;46(1):55-62. doi: 10.1139/apnm-2020-0284. Epub 2020 Jul 16.
- Kuk JL, Lee S. Sex and Ethnic Differences in the Relationship between Changes in Anthropometric Measurements and Visceral Fat in Adolescents with Obesity. J Pediatr. 2019 Oct;213:121-127. doi: 10.1016/j.jpeds.2019.05.052. Epub 2019 Jun 22.
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
November 1, 2007
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
August 20, 2008
First Submitted That Met QC Criteria
August 20, 2008
First Posted (Estimate)
August 21, 2008
Study Record Updates
Last Update Posted (Estimate)
November 6, 2012
Last Update Submitted That Met QC Criteria
November 2, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7-08-JF-27
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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