Intensive Exercise to Improve Mitochondrial Dysfunction in Pediatric Obesity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Amy Fleischman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00962806
First received: August 18, 2009
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

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 for the development of insulin resistance, relative insulin deficiency and type 2 diabetes mellitus (DM). The prevention of type 2 DM is hindered by the lack of a non-invasive predictive test, knowledge as to individual risk and effective preventative measures. There is increasing evidence that alterations in mitochondria contribute to the development of diabetes in humans. Therefore, it is important to explore mitochondrial dysfunction as a potential predictor of diabetes in children and a potential target for prevention. The aims of the proposed protocol are to determine whether an intensive exercise intervention can improve mitochondrial function in children identified as having mitochondrial dysfunction and insulin resistance. The use of a non-invasive imaging technique will allow for a functional in vivo assessment of mitochondrial activity. The investigators propose the investigation of an intensive exercise protocol designed to improve mitochondrial function in children who are insulin resistant and have documented mitochondrial dysfunction by magnetic resonance spectroscopy. The study is designed to investigate the plasticity of abnormal mitochondrial function in high risk children. In summary, the proposed projects will investigate mitochondrial function as a non-invasive predictive marker for the development of insulin resistance and type 2 diabetes mellitus in children and attempt to modify mitochondrial function with an intensive exercise intervention. The study of mitochondrial dysfunction in children may both identify those at risk for disease and provide a molecular therapeutic target for prevention and treatment.

The investigators hypothesize that children with insulin resistance and mitochondrial dysfunction who are randomized to intensive exercise versus standard lifestyle advice will show improvement in mitochondrial function and insulin sensitivity.


Condition Intervention
Pediatric Obesity
Insulin Resistance
Mitochondrial Dysfunction
Behavioral: Exercise
Behavioral: Lifestyle counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intensive Exercise to Improve Mitochondrial Dysfunction in Pediatric Obesity

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Determine whether intensive exercise improves mitochondrial function by P31 MRS and mitochondrial number by peripheral blood analyses. [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine whether intensive exercise improves metabolic parameters and glucose metabolism. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Determine whether intensive exercise improves body composition, by DXA, and intramyocellular fat content, by 1H MRS. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exercise
8 week intensive exercise group
Behavioral: Exercise
8 weeks of intensive exercise, 60-90 minutes 3 days each week
Control Lifestyle counseling
Lifestyle counseling without intensive exercise
Behavioral: Lifestyle counseling
Baseline and final visit dietary and activity advice and weekly healthy lifestyle messages

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  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: NCT00962806

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Amy Fleischman, MD, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00962806     History of Changes
Other Study ID Numbers: DK084118, Partners IRB: 2009P-000173
Study First Received: August 18, 2009
Last Updated: April 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Pediatric obesity
Insulin resistance
Diabetes
Mitochondria

Additional relevant MeSH terms:
Obesity
Insulin Resistance
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014