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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Obesity
Obesity, Abdominal
Diabetes Mellitus, Type 2
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 August 28, 2014