Status:
COMPLETED
Study of Serum Markers for Cardiovascular Risk in Obese Youth and Impact of Lifestyle and Medication Intervention
Lead Sponsor:
Nemours Children's Clinic
Collaborating Sponsors:
Thrasher Research Fund
Conditions:
Obesity
Eligibility:
All Genders
7-18 years
Phase:
NA
Brief Summary
In Protocol #2, we will select 30 obese pubertal and 30 obese prepubertal subjects with an abnormal cytokine profile (i.e. fibrinogen and/or hsCRP concentration greater than or equal to 2 Standard Dev...
Eligibility Criteria
Inclusion
- Ages 7-18 years.
- Greater than the 95th 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.
- Must pass the screening test done in Protocol #1.
- Must have higher values than normal for certain blood tests related to heart disease that were measured in Protocol #1.
Exclusion
- 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.
- Impaired fasting glucose.
- Dyslipidemia.
- Actively in puberty.
- Weight greater than 300 pounds.
- Metal in the abdomen.
- History of being overweight greater than 5 years.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00139477
Start Date
November 1 2003
End Date
September 1 2011
Last Update
April 18 2023
Active Locations (1)
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1
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207