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. We 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.

We 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.

We hypothesize that these cardiovascular risks can be reduced with lifestyle and drug interventions.

Condition	Intervention
Obesity	Drug: Metformin  Behavior: Dietary modification with caloric restriction  Behavior: Establishment of exercise protocol

Further Study Details: 

Primary Outcomes: To determine if obese children without other features of the metabolic syndrome have increases in serum markers for cardiovascular risk even before the onset of puberty as compared to lean controls.
Secondary Outcomes: To determine if exercise, diet, and/or drug therapy can improve the pro-thrombotic and pro-inflammatory state of obesity that we postulate exists prior to the metabolic syndrome.
Expected Total Enrollment:  160

Ages Eligible for Study:  8 Years   -   18 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00139477

Kim Walker      904-858-3026    jaxendo@nemours.org

Florida
      Nemours Children''''s Clinic, Jacksonville,  Florida,  32207,  United States; Recruiting

Study chairs or principal investigators

Nelly Mauras, MD,  Principal Investigator,  Nemours Children''''s Clinic   

Study ID Numbers:  04-032
Last Updated:  September 1, 2005
Record first received:  August 29, 2005
ClinicalTrials.gov Identifier:  NCT00139477
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-06