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

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323088
• Other study ID #: 1R21DK083654-01A1
• Status: Completed
• Phase: N/A
• First received: March 22, 2011
• Last updated: April 12, 2013
• Start date: August 2010
• Est. completion date: October 2012

Study information

• Verified date: April 2013
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Obesity
• Obesity, Abdominal
• Physical Activity

Intervention

Other:
• Control
Standard care control (no exercise)
• Resistance Exercise
Supervised resistance exercise using stack weight equipments.
• Aerobic exercise
Supervised aerobic exercise using treadmills, bikes, and ellipticals

Locations

Country	Name	City	State
United States	Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal obesity, visceral fat		3 month	No
Secondary	insulin sensitivity by a 3-hour hyperinsulinemic-euglycemic clamp, oral glucose tolerance test, liver fat and intramyocellular lipid by 1H-magnetic resonance spectroscopy.		3 month	No