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Post-Prandial Liver Glucose Metabolism in PCOS
Bu çalışma, polikistik over sendromu (polycystic ovary syndrome, PCOS) olan genç kadınlarda öğün sonrası (postprandiyal) karaciğerin glukoz (şeker) metabolizmasını incelemektedir. Bunun için oral glukoz tolerans testi ve karaciğerin MR görüntülemesi kullanılmıştır. Çalışmaya, 12-21 yaş arası, vücut kitle indeksi yüksek kadınlar alınmıştır. Çalışma faz uygulanmayan bir çalışma olarak yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
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
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