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 @ 10:12 PM
Ignite Modification Date:
2025-12-24 @ 10:12 PM
NCT ID:
NCT03717935
Eligibility Criteria:
Inclusion Criteria:
1. Females
2. Ages 12-21
3. Sedentary- less than 2 hours of moderate (jogging, swimming etc) exercise a week.
4. BMI equal or greater than the 90th percentile for age and gender
5. PCOS per the most stringent NIH criteria adapted for adolescents (irregular menses \>24 months post-menarche and clinical or biochemical hypertestosteronemia)
6. HS per FibroScan ultrasound, with CAP score of \>225 (will be measured at screening visit)
Exclusion Criteria:
1. Use of medications known to affect insulin sensitivity: metformin, oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant agents, HIV medications, hormonal contraception. Dermal patch or vaginal ring contraception methods.
2. Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study.
3. Severe illness requiring hospitalization within 60 days
4. Diabetes, defined as Hemoglobin A1C \> 6.4%
5. BMI percentile less than the 90th percentile for age and sex. Weight \>325 lbs or \<84 lbs.
6. Anemia, defined as Hemoglobin \< 11 mg/dL
7. Diagnosed major psychiatric or developmental disorder limiting informed consent
8. Implanted metal devices that are not compatible with MRI
9. Use of blood pressure medications
10. Known liver disease other than NAFLD or AST or ALT \>125 IU/L
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
12 Years
Maximum Age:
21 Years
Study:
NCT03717935
Study Brief:
Protocol Section:
NCT03717935