Physical Activity in Youth: Implications for Reversing Risk Factors for Type 2 Diabetes
Primary Purpose
Abdominal Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control
Resistance Exercise
Aerobic exercise
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Obesity focused on measuring Childhood obesity, Abdominal obesity, Visceral fat, Insulin resistance, Liver fat, Skeletal muscle lipid, Fitness
Eligibility 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
Sites / Locations
- Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Active Comparator
Active Comparator
Arm Label
Control
Aerobic Exercise
Resistance Exercise
Arm Description
Standard care control
Outcomes
Primary Outcome Measures
Abdominal obesity, visceral fat
Secondary Outcome Measures
Insulin sensitivity and secretion, glucose tolerance
Full Information
NCT ID
NCT00739180
First Posted
August 20, 2008
Last Updated
November 2, 2012
Sponsor
University of Pittsburgh
Collaborators
American Diabetes Association
1. Study Identification
Unique Protocol Identification Number
NCT00739180
Brief Title
Physical Activity in Youth: Implications for Reversing Risk Factors for Type 2 Diabetes
Official Title
Physical Activity in Youth: Implications for Reversing Risk Factors for Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
American Diabetes Association
4. Oversight
Data Monitoring Committee
Yes
5. 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, and risk of type 2 diabetes in overweight children and adolescents.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Obesity
Keywords
Childhood obesity, Abdominal obesity, Visceral fat, Insulin resistance, Liver fat, Skeletal muscle lipid, Fitness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Other
Arm Description
Standard care control
Arm Title
Aerobic Exercise
Arm Type
Active Comparator
Arm Title
Resistance Exercise
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Standard care control (no exercise)
Intervention Type
Other
Intervention Name(s)
Resistance Exercise
Intervention Description
Supervised resistance exercise using stack weight equipments.
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Intervention Description
Supervised aerobic exercise using treadmills, bikes, and ellipticals
Primary Outcome Measure Information:
Title
Abdominal obesity, visceral fat
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Insulin sensitivity and secretion, glucose tolerance
Time Frame
3 month
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SoJung Lee, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33739874
Citation
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.
Results Reference
derived
PubMed Identifier
32674604
Citation
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.
Results Reference
derived
PubMed Identifier
31235380
Citation
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.
Results Reference
derived
Learn more about this trial
Physical Activity in Youth: Implications for Reversing Risk Factors for Type 2 Diabetes
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