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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT03041129

NCT03041129
Completed Not Applicable

Who may be able to join

Who might be able to join this trial:

  • You are female
  • You are between 12 and 21 years old
  • You are not very physically active — meaning you do less than 2.5 hours of moderate exercise (like jogging or swimming) per week
  • Your BMI (body mass index) is at or above the 90th percentile for your age and gender (meaning higher than most people your age)
  • For the PCOS groups only: Your periods have been irregular for at least 1.5 years since your first period, AND you either show signs of higher-than-normal male hormones, or blood tests have shown elevated testosterone levels
  • For the PCOS groups only: You are either not currently being treated, or you have been taking Metformin (1500–2000 mg per day) or a specific type of birth control pill for at least 6 months, and you have taken it as directed more than 80% of the time
  • For the non-PCOS groups only: Your periods have been regular for at least 1.5 years since your first period, and you do not show signs of higher-than-normal male hormones

Who may not be able to join:

  • You are currently taking certain medications that affect how your body handles blood sugar, including oral steroids (taken within the last 10 days), certain antipsychotic medications, medications that suppress the immune system, or HIV medications
  • You currently use certain types of contraception, including the Nexplanon implant, Depo-Provera injection, Mirena IUD, a skin patch, or a vaginal ring
  • For the non-PCOS (control) group only: You are currently taking Metformin or birth control pills
  • You are currently pregnant or breastfeeding
  • You have been hospitalised for a serious illness in the last 60 days
  • You have diabetes, based on a specific blood test result (confirm with trial site)
  • Your BMI is below the 90th percentile for your age and sex
  • You weigh more than 325 lbs or less than 84 lbs
  • You have anaemia (low levels of red blood cells), based on a specific blood test result (confirm with trial site)
  • You have a diagnosed major psychiatric or developmental condition that would make it difficult to give informed consent
  • You have any metal implants in your body that are not safe for MRI scans
  • You are currently taking blood pressure medications
  • You have a known liver disease other than fatty liver disease, or certain liver enzyme levels are too high (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Trial details

Status
Completed
Phase
Not Applicable
Sponsor
University of Colorado, Denver
Registry
clinicaltrials_gov
Start date
14 April 2017
Est. completion
29 August 2018

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Hepatic Fat Fraction

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov