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 range
12 Years – 21 Years
Sex
FEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)
. 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
. Diagnosed major psychiatric or developmental disorder limiting informed consent
. Implanted metal devices that are not compatible with MRI