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

NCT03717935

NCT03717935
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 exercise less than 2 hours per week of moderate activity (such as jogging or swimming)
  • Your BMI is at or above the 90th percentile for your age and gender (meaning you are in the heavier range compared to others your age)
  • You have been diagnosed with Polycystic Ovary Syndrome (PCOS) with irregular periods more than 24 months after your first period started, and higher-than-normal testosterone levels
  • You have been found to have fatty liver disease, confirmed by a special scan called a FibroScan, with a specific score above 225 (this will be checked at your first visit)

Who may not be able to join:

  • You are currently taking certain medications, including metformin, steroid tablets (taken within the last 10 days), certain antipsychotic medications, immune-suppressing drugs, HIV medications, or hormonal contraception including patches or vaginal rings
  • You are currently pregnant or breastfeeding (and becoming pregnant during the study would also mean you would need to leave the study)
  • You have been seriously ill and needed to be in hospital within the last 60 days
  • You have diabetes, based on a specific blood test result (HbA1c above 6.4%)
  • Your BMI is below the 90th percentile for your age and sex, or you weigh more than 325 lbs or less than 84 lbs
  • You have anaemia (low levels of a protein in your blood called haemoglobin, below 11 mg/dL)
  • You have a diagnosed major psychiatric or developmental condition that affects your ability to give informed consent
  • You have any metal implants in your body that are not safe to use with an MRI scanner
  • You are currently taking blood pressure medications
  • You have a known liver disease other than fatty liver disease, or certain liver enzyme levels in your blood 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
8 October 2018
Est. completion
14 January 2022

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