Status:

UNKNOWN

Intensive Exercise to Improve Mitochondrial Dysfunction in Pediatric Obesity

Lead Sponsor:

Massachusetts General Hospital

Collaborating Sponsors:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Conditions:

Pediatric Obesity

Insulin Resistance

Eligibility:

All Genders

10-18 years

Phase:

NA

Brief Summary

Obesity and type 2 diabetes are occurring at epidemic rates in the United States and worldwide. The global burden of diabetes is estimated to double over the next 25 years. Obese children are at risk ...

Eligibility Criteria

Inclusion

  • Girls and boys ages 10 to 18 years old
  • Body mass index more than 95th percentile for age and gender
  • Insulin resistance based on:
  • Fasting parameters: Fasting insulin level, HOMA IR
  • Oral glucose tolerance testing
  • Mitochondrial function \> 1 median for normal based on control cohort

Exclusion

  • Underlying medical problem with potential to affect growth, pubertal development or glucose homeostasis
  • Chronic medical therapy with glucocorticoids, growth hormone, estrogen, progesterone, testosterone, or other medications with the potential to alter growth, pubertal development or glucose homeostasis within the proceeding 6 months
  • Personal history of DM
  • Inability to have MRI scan performed due to metal prosthesis or implant

Key Trial Info

Start Date :

August 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2012

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT00962806

Start Date

August 1 2009

End Date

December 1 2012

Last Update

April 27 2012

Active Locations (1)

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1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114