Intensive Exercise to Improve Mitochondrial Dysfunction in Pediatric Obesity

NCT ID: NCT00962806

Last Updated: 2012-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2012-12-31

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.

Conditions

Pediatric Obesity; Insulin Resistance; Mitochondrial Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise

8 week intensive exercise group

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: BEHAVIORAL

8 weeks of intensive exercise, 60-90 minutes 3 days each week

Control Lifestyle counseling

Lifestyle counseling without intensive exercise

Group Type: OTHER

Lifestyle counseling

Intervention Type: BEHAVIORAL

Baseline and final visit dietary and activity advice and weekly healthy lifestyle messages

Interventions

Exercise

8 weeks of intensive exercise, 60-90 minutes 3 days each week

Intervention Type: BEHAVIORAL

Lifestyle counseling

Baseline and final visit dietary and activity advice and weekly healthy lifestyle messages

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Amy Fleischman, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

Partners IRB: 2009P-000173

Identifier Type: -

Identifier Source: secondary_id

DK084118

Identifier Type: -

Identifier Source: org_study_id