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Sponsors and Collaborators: |
Nemours Children's Clinic Thrasher Foundation |
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Information provided by: | Nemours Children's Clinic |
ClinicalTrials.gov Identifier: | NCT00139477 |
The purpose of this study is to evaluate whether serum markers of inflammation and thrombosis, which ultimately increase cardiovascular risk (CRP, fibrinogen and others) are already abnormal in obese children that do not yet have other features of the metabolic syndrome. The investigators will assess the status of these risk factors in pubertal and prepubertal children ages 8-18 years, both lean and obese. The pubertal cohort that has elevations in these markers will participate in a longitudinal interventional study with lifestyle modification (diet and structured exercise) with or without Metformin for 6mo in a cross over design. Intrahepatic fat contents will be measured as well.
The investigators hypothesize that obese children in these age groups will have increased cardiovascular risk related to their obese state before reaching the currently defined criteria of metabolic syndrome. The investigators hypothesize that these cardiovascular risks can be reduced with lifestyle and drug interventions.
Condition | Intervention |
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Obesity |
Drug: Metformin Behavioral: Dietary modification with caloric restriction Behavioral: Establishment of exercise protocol |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Understanding the Effects of Therapeutic Intervention on Cardiovascular Risk Markers, Insulin Resistance, and Intra-Hepatic Fat Contents in Obese Children at High Risk for the Metabolic Syndrome. |
Estimated Enrollment: | 160 |
Study Start Date: | June 2005 |
Ages Eligible for Study: | 8 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Nemours Children's Clinic | |
Jacksonville, Florida, United States, 32207 |
Principal Investigator: | Nelly Mauras, MD | Nemours Children's Clinic |
Study ID Numbers: | 04-032 |
Study First Received: | August 29, 2005 |
Last Updated: | February 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00139477 History of Changes |
Health Authority: | United States: Institutional Review Board |
Body Weight Signs and Symptoms Obesity Metformin Nutrition Disorders |
Overweight Overnutrition Insulin Resistance Insulin |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |