Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOS (NCT03717935) | Clinical Trial Compass
CompletedNot Applicable
Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOS
United States27 participantsStarted 2018-10-08
Plain-language summary
The Investigators will measure hepatic glucose and fat metabolism in obese girls with Polycystic Ovarian Syndrome (PCOS) and hepatic steatosis (HS) after taking 4 weeks of an essential amino acid (EAA) supplement or placebo and test whether the EAA supplement can improve hepatic glucose metabolism in these girls.
Who can participate
Age range12 Years – 21 Years
SexFEMALE
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Inclusion criteria
✓. Females
✓. Ages 12-21
✓. Sedentary- less than 2 hours of moderate (jogging, swimming etc) exercise a week.
✓. BMI equal or greater than the 90th percentile for age and gender
✓. PCOS per the most stringent NIH criteria adapted for adolescents (irregular menses \>24 months post-menarche and clinical or biochemical hypertestosteronemia)
✓. HS per FibroScan ultrasound, with CAP score of \>225 (will be measured at screening visit)
Exclusion criteria
✕. 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.
✕. Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study.
✕. Severe illness requiring hospitalization within 60 days
✕. Diabetes, defined as Hemoglobin A1C \> 6.4%
✕. BMI percentile less than the 90th percentile for age and sex. Weight \>325 lbs or \<84 lbs.
✕. Anemia, defined as Hemoglobin \< 11 mg/dL
What they're measuring
1
Hepatic Fat Fraction
Timeframe: 4 weeks after completing the first intervention, and approximately 8 weeks later (4 weeks washout and 4 weeks of second intervention)