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 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT00579904
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of polycystic ovary syndrome
* Body mass index (BMI) 22-52
Exclusion Criteria:
* Habitual dietary intake of less than 30% fat
* Use of oral contraceptives, insulin sensitizers, d-chiro inositol, or any other supplements affecting weight or insulin sensitivity during the preceding two months
* Impaired glucose tolerance
* Diabetes mellitus
* Other system illnesses such as renal, hepatic, gastrointestinal, severe hyperlipidemia and hypertension that require medication
* Smoking, alcohol intake (more than 2 drinks/week)
* The laboratory values used for exclusion of subjects will be fasting glucose \> 110 mg/dl, glycosylated hemoglobin (HgBA1) \> 6.5%, serum creatinine \> 1.5 mg/dl, ALT or AST \> 2x the upper limit of normal, cholesterol \> 250 mg/dl. The investigators will also exclude subjects with hematocrit \< 30%.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00579904
Study Brief:
Protocol Section:
NCT00579904