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NCT00460135 Clinical Trial

The Impact of Resistance Exercise Training On Metabolic Dysregulation in Obese Children.

Insulin Resistance Clinical Trial

Official title:
The Impact of Resistance Exercise Training On Metabolic Dysregulation in Obese Children.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00460135
Other study ID # PED-06-004
Secondary ID
Status Completed
Phase N/A
First received April 11, 2007
Last updated March 3, 2009
Start date April 2006
Est. completion date July 2008

Study information
Verified date March 2009
Source McGill University Health Center
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

Impact of resistance training in prepubertal children with obesity focusing mostly in changes in body composition and markers of insulin resistance.

Hypothesis is that this will show positive changes in this randomized controlled trial.

Description:

24 obese prepubertal obese children randomized to either resistance training program or usual care for 12 weeks. Baseline blood profiles and DEXA scans done before and after 12 weeks of training with the help of kinesiology graduates from Concordia University kinesiology department.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 8 Years to 12 Years
Eligibility Inclusion Criteria:

- Between 8-12y

- Prepubertal

- Not on medications with known impact on weight loss

Exclusion Criteria:

- Pubertal

- Uncontrolled thyroid condition

- Type 2 diabetes

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• resistance training
2 times a week resistance training

Locations
Country Name City State
Canada Montreal Children's Hospital Montreal Quebec

Sponsors (1)
Lead Sponsor Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in body composition as per DEXA scans 12 weeks No
Secondary Changes in insulin resistance as per HOMA score 12 weeks No
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