Intensive Exercise to Improve Mitochondrial Dysfunction in Pediatric Obesity
2 other identifiers
interventional
40
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 18, 2009
CompletedFirst Posted
Study publicly available on registry
August 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedApril 27, 2012
April 1, 2012
2.8 years
August 18, 2009
April 25, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine whether intensive exercise improves mitochondrial function by P31 MRS and mitochondrial number by peripheral blood analyses.
2 year
Secondary Outcomes (2)
Determine whether intensive exercise improves metabolic parameters and glucose metabolism.
2 years
Determine whether intensive exercise improves body composition, by DXA, and intramyocellular fat content, by 1H MRS.
2 years
Study Arms (2)
Exercise
ACTIVE COMPARATOR8 week intensive exercise group
Control Lifestyle counseling
OTHERLifestyle counseling without intensive exercise
Interventions
Baseline and final visit dietary and activity advice and weekly healthy lifestyle messages
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 18, 2009
First Posted
August 20, 2009
Study Start
August 1, 2009
Primary Completion
June 1, 2012
Study Completion
December 1, 2012
Last Updated
April 27, 2012
Record last verified: 2012-04