Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT00185705
Eligibility Criteria:
Inclusion Criteria:
Ages between 10.00 and 17.99 years
Body mass index (BMI) ≥ 95th percentile for age and gender using the CDC data
SBP ≥ 95th percentile for age, gender, and height using the fourth report from the National High Blood Pressure Education Program (NHBPEP) guidelines.
Fasting plasma insulin concentration ≥ 20 U/mL will be required for study entry. This insulin concentration is commonly used for defining insulin resistance.
Exclusion Criteria:
Subjects will be excluded from the study if they have known diabetes as defined by the American Diabetes Association criteria, prior drug therapy to treat diabetes or insulin resistance, recent glucocorticoid therapy within 3 months of the screening visit, current drug therapy to treat hypertension, elevated creatinine (\> 1.2mg/dL), elevated liver enzymes (ALT \> 80), history or current alcohol ingestion, existing pregnancy or high-risk of becoming pregnant, other serious medical condition that the investigator determines may put the subject at undue risk if enrolled in the study, or taking medications with potential drug-drug interactions (anticoagulant, digoxin, diuretics).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
18 Years
Study:
NCT00185705
Study Brief:
Protocol Section:
NCT00185705