CompletedNot Applicable

Post-Prandial Liver Glucose Metabolism in PCOS

United States19 participantsStarted 2017-04-14

Plain-language summary

The Investigators will measure if hepatic metabolism is upregulated in obese girls with PCOS and hepatic steatosis (HS), compared to PCOS without HS and obese controls without HS.

Who can participate

Age range

12 Years – 21 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Female
. Ages 12-21
. Sedentary- less than 2.5 hours of moderate (jogging, swimming etc) exercise a week.
. BMI equal or greater than the 90th percentile for age and gender
. For PCOS groups:
. For PCOS groups:
. For non-PCOS groups:

Exclusion criteria

. Use of medications known to affect insulin sensitivity:
. 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.

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

Hepatic Fat Fraction

Timeframe: Measured up to 4 months from enrollment

Trial details

NCT IDNCT03041129

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-08-29

Results submitted2022-05-06

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