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 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT01068535
Eligibility Criteria:
Inclusion Criteria:
* Pre-menopausal women (age 35-50)
* still having menstrual periods
Exclusion Criteria:
* History of diabetes mellitus
* History of cardiovascular disease (peripheral vascular disease, coronary artery disease, cerebrovascular disease)
* Serum creatinine \>1.2 mg/dL (eGFR \<60 ml/min.)
* Active rheumatologic disease
* Use of hormonal contraception\*
* Pregnant or planning a pregnancy within the next 3 months
* Fasting triglycerides ≥ 500 mg/dL
* Fasting LDL-C ≥ 190 mg/dL
* Currently taking lipid lowering medications\*
* Currently taking vaso-active (blood pressure) medications\*
* Hypertension: SBP ≥ 140 and or DBP ≥90 mm Hg
* Chronic use of aspirin (prn use is allowed)
* Chronic use of non-steroidal anti-inflammatory medications (prn use is allowed)
* Tobacco use within 3 months of starting study
* Participation in another clinical trial within the last 30 days
* MRI specific exclusion criteria:
* History of claustrophobia
* History of decrease in kidney function (eGFR \<60 ml/min.)
* History of reaction to a contrast medium or dye used for an MRI, CT Scan, or X-ray
* History of significant anemia or other blood disease
* History of seizures
* MRI-incompatible metal such as internal metal hardware or devices \* Drugs within the following classifications are exclusionary: Antilipemics, antilipidemics, beta blockers, ACE inhibitors, angiotensin receptor blockers, diuretics, calcium channel blockers, alpha blockers, nitrates, and all hormonal contraceptives
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
35 Years
Maximum Age:
50 Years
Study:
NCT01068535
Study Brief:
Protocol Section:
NCT01068535