Expired Study
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Jacksonville, Florida 32207


Purpose:

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.


Criteria:

Inclusion Criteria: - Ages 8-18 years. - Obese children are greater than the 95th percentile body mass index for their age and gender. - Lean children are between the 10th and 50th percentile body mass index for their age and gender. - Children are in Tanner Stage I or IV or V. - Normal Blood Pressure. - Normal fasting glucose. - Normal lipids. - Menstruating girls must have completed their most recent period at least 2 weeks prior to blood draw. - NO recent illness, no chronic illnesses, no routine medications, no smoking or alcohol intake. Exclusion Criteria: - Chronic active illnesses. - Recent illnesses. - Use of routine medications, vitamins, herbal remedies, oral contraceptive pills, or other over the counter medications within 4 weeks of blood draw. - History of recent or chronic smoking. - Currently pregnant. - For the lean control group, immediate family history of Type 2 Diabetes mellitus or Hypertension or Hyperlipidemia. - Impaired fasting glucose. - Dyslipidemia. - Actively in puberty. - Weight greater than 300 pounds.


NCT ID:

NCT00139477


Primary Contact:

Principal Investigator
Nelly Mauras, MD
Nemours Children's Clinic


Backup Contact:

N/A


Location Contact:

Jacksonville, Florida 32207
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

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