Healia Clinical Trials Information Database

Mitochondrial Function in Pediatric Obesity

The prevalence of pediatric obesity is increasing at an unprecedented rate. Obese children are at risk for the development of insulin resistance, relative insulin deficiency and type 2 diabetes mellitus. However, the cause of insulin resistance remains an area of scientific interest. The study of type 2 diabetes in children is limited by the lack of a non-invasive method to evaluate insulin resistance. Recent studies have suggested that mitochondrial dysfunction is associated with, and perhaps predictive of insulin resistance in adult relatives of individuals with type 2 diabetes. Mitochondria generate energy in muscle tissue through the production of ATP, and are important in the metabolism of both glucose and fat. This study evaluates a novel, non invasive, safe method for predicting insulin resistance and diabetes in children using a magnetic resonance imaging (MRI) based technique to measure mitochondrial function. We propose to investigate mitochondrial function and glucose metabolism in obese and non-obese children in early, mid and late puberty. Analyses will be conducted to investigate the presence of mitochondrial dysfunction in obese children, to evaluate the contribution of mitochondrial dysfunction to insulin resistance, and to determine the contribution of pubertal status to mitochondrial dysfunction and insulin resistance. The successful completion of this study would provide evidence to support the hypothesis that mitochondrial dysfunction plays a role in insulin resistance and diabetes in children. In addition, it would provide a new technique for the prediction of disease states and perhaps lead to the development of preventative therapeutics for insulin resistance and type 2 diabetes in children.

We hypothesize that mitochondrial dysfunction will mirror the progression of insulin resistance and precede and predict abnormal glucose metabolism in a population with pediatric obesity

Description

Aim I: A cross sectional study to evaluate baseline mitochondrial function in obese children compared to non-obese children. Determine whether children with pediatric obesity have impaired mitochondrial function based on 31P magnetic resonance spectroscopy when compared to healthy non-obese control children.Examine the relationship between mitochondrial function and insulin resistance in obese and non-obese children. Determine the impact of pubertal stage on mitochondrial function in obese and non-obese children.

Aim II:A prospective evaluation to determine in a longitudinal cohort study the timing and relationship of mitochondrial dysfunction to the development of insulin resistance in prepubertal/early pubertal obese children compared to prepubertal/early pubertal non-obese children. Determine in a longitudinal cohort study if obese children with mitochondrial dysfunction develop greater insulin resistance and/or impaired glucose tolerance at an earlier time point. Evaluate the relationship of obesity, timing of puberty and related changes in hormone levels to mitochondrial function and the development of insulin resistance and/or impaired glucose tolerance in longitudinal analyses.

Status: Recruiting (N/A). Started on June 1st, 2007.

Enrollment: 110 subjects

Study Type: Observational

Study Design:

  • Observational Model: Case Control

Conditions:

Interventions:


Eligibility

Inclusion Criteria:

  1. Girls and boys ages 8 to 18 years old

  2. Non-obese cohort: body mass index less than 75th percentile for age

  3. Obese cohort: body mass index more than 95th percentile for age

Exclusion Criteria:

  1. Underlying medical problem with potential to affect growth, pubertal development or glucose homeostasis

  2. 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

  3. Personal history of diabetes

  4. Family history of diabetes in first degree relative

  5. Inability to have MRI scan performed due to metal prosthesis or implant

Gender

Both

Mininum Age

8 Years

Maximum Age

18 Years

Healthy Volunteers

Accepts Healthy Volunteers


Resources

Source: Massachusetts General Hospital

Authority: United States: Institutional Review Board

Locations

  • Massachusetts General Hospital
    Boston
    Massachusetts
    02114
    United States

Officials

  • Amy D Fleischman, MD, MMSc (Principal Investigator, Massachusetts General Hospital)

Sponsors

  • Massachusetts General Hospital (Lead Sponsor)

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

  • Lawson Wilkins Pediatric Endocrine Society (Collaborator)

  • Children's Hospital Boston (Collaborator)

References

None.

Links

None.


Date Verified
September 1st, 2010
First Received
September 29th, 2010
Last Changed
September 29th, 2010

Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.


All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.

The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.


Advertisements

About | Privacy Policy | Business Solutions | Advertise | Contact | Add Healia to your site

©2012. Healia / Meredith Corporation  

Use of this site constitutes acceptance of our Terms of Service and Privacy Policy. All content on this Web site, including medical opinion and any other health-related information, is for informational purposes only and should not be used for a specific diagnosis or individual treatment plan for any situation. Use of this site and the information contained herein does not create a doctor-patient relationship. Always seek the direct advice of your doctor in connection with any questions or issues you may have regarding your own health or the health of others.