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 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT04116203
Eligibility Criteria:
Inclusion Criteria:
* Female
* Age at time of enrollment \> 18 to \<30 years
* Diagnosis of PCOS: clinical and/or biochemical hyperandrogenemia and menstrual dysfunction and the exclusion of other disorders.
* Overweight-obese (BMI \>25 kg/m2) high-risk metabolically-resistant young women.
* Elevated fasting plasma TG (\>150 mg/dL) and apoB48-remnant cholesterol lipoproteins (\>20 ug/ml).
* Impaired insulin sensitivity (glucose 100-125 mg/dL and/or insulin \>15 (uM/ml); and
* May be diagnosed with T2D (blood glucose \>126 mg/dL).
Exclusion Criteria:
* Pregnancy
* Lactating women
* Recent illness that the investigator determines to pose a potential risk for the participant
* Concomitant medications that influence metabolism (e.g. statins)
* Excessive alcohol consumption, as determined by the investigator.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
30 Years
Study:
NCT04116203
Study Brief:
Protocol Section:
NCT04116203