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:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT00111956
Eligibility Criteria:
Inclusion Criteria:
* Hyperinsulinemia in the upper quartile of the non-diabetic population defined as ≥10 mU/mL (Framingham Data, oral communication, James Meigs, MD) or fasting glucose 110-126 mg/dL, plus two of the following: \*Abdominal obesity defined by waist hip ratio \> 0.90 for men and \> 0.85 for women or \*body mass index (BMI) \> 30 kg/m2
* Dyslipidemia including serum triglycerides ≥150 mg/dl or serum HDL \< 0.9 mmol/L for men (35 mg/dL) and \< 1.0 mmol/L (39 mg/dL) for women
* Hypertension defined as blood pressure ≥ 140/90 or on medication
Exclusion Criteria:
* Positive PPD (≥ 5mm induration) on screening
* Current infection
* Therapy with glucocorticoid or immunosuppressant at time of recruitment or within past 3 months
* Reception of live vaccine within 1 week of recruitment
* History of blood dyscrasia including any kind of anemia, thrombocytopenia, pancytopenia. Women with a reversible cause of anemia that has resolved will be eligible.
* History of malignancy (except patients with surgically cured basal cell or squamous cell skin cancers who will be eligible)
* History of organ transplantation
* History of central nervous system (CNS) demyelinating disorder or any first degree relative with multiple sclerosis
* History of congestive heart failure (CHF) classes I-IV
* Current use of insulin, any oral anti-hyperglycemic agents, pentoxyfylline, beta-agonists
* Current use of fibrate or niacin
* Initiation of statin therapy within prior 6 weeks or expecting a change in statin dose over the upcoming 3 months
* Hemoglobin \< 11 g/dl
* Positive pregnancy test
* Women of child-bearing potential not currently using non-hormonal birth control methods including barrier methods (intrauterine device (IUD), condoms, diaphragms) or abstinence
* Patients with known autoimmune or inflammatory conditions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00111956
Study Brief:
Protocol Section:
NCT00111956