Yükleniyor... / Loading...
This study examines the liver's glucose (sugar) metabolism after meals in young women with polycystic ovary syndrome (PCOS). It used an oral glucose tolerance test and MRI imaging of the liver. It enrolled women aged 12-21 with a high body mass index. This was a study with no assigned phase and it has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria:
1. Female
2. Ages 12-21
3. Sedentary- less than 2.5 hours of moderate (jogging, swimming etc) exercise a week.
4. BMI equal or greater than the 90th percentile for age and gender
5. For PCOS groups:
* (NIH definition) irregular menstrual cycles at least 1.5 years after menarche, and
* either clinical evidence of hyperandogenism, or
* elevated Testosterone (above the norms for age/tanner stage) at time of screening, or documented prior to initiation of therapy for OCP and metformin groups.
6. For PCOS groups:
* patients un-treated or currently treated with either Metformin 1500-2000 mg a day, or
* oral contraception (30-35 mcg ethynyl estradiol a day) for at least 6 months, with \> 80% adherence confirmed via refill frequency from pharmacy.
7. For non-PCOS groups:
* regular menstrual cycles at least 1.5 years after menarche, and
* no clinical evidence of hyperandrogenism.
Exclusion Criteria:
1. Use of medications known to affect insulin sensitivity:
* oral glucocorticoids within 10 days,
* atypical antipsychotics,
* immunosuppressant agents,
* HIV medications.
* Nexplanon, Depo-Provera or Mirena progesterone only contraceptives.
* Dermal patch or vaginal ring contraception methods.
* For controls only: metformin or oral contraception.
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.
6. Weight \>325 lbs or \<84 lbs.
7. Anemia, defined as Hemoglobin \< 10 mg/dL
8. Diagnosed major psychiatric or developmental disorder limiting informed consent
9. Implanted metal devices that are not compatible with MRI
10. Use of blood pressure medications
11. Known liver disease other than NAFLD or AST or ALT \>150 mg/mL
\-