Clinical Trials Directory

Trials / Completed

CompletedNCT03041129

Post-Prandial Liver Glucose Metabolism in PCOS

Post-Prandial Liver Glucose Metabolism in Polycystic Ovarian Syndrome (PCOS) and Understanding Standard of Care Medications

Status
Completed
Phase
Study type
Observational
Enrollment
19 (actual)
Sponsor
University of Colorado, Denver · Academic / Other
Sex
Female
Age
12 Years – 21 Years
Healthy volunteers
Accepted

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.

Detailed description

This will be a cross-sectional study with 4 groups of youth. A 6 hour OSTT (Oral Sugar Tolerance Test) with an oral U-C13 glycerol tracer will be paired with nuclear magnetic resonance spectroscopy (NMR) isotopomer analysis of serum samples to describe flux through the hepatic pentose phosphate pathway, TCA cycle and FAS pathways in girls with PCOS receiving lifestyle only, metformin or oral contraceptive treatment, and obese girls with regular menses receiving lifestyle therapy. Hepatic steatosis will be measured with MRI. Please note that 3 study groups: PCOS on metformin, PCOS on oral contraceptive treatment, and obese girls with regular menses were not funded in the study, so no participants were enrolled in these 3 arms of the study.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESToral glucose tolerance test6 hours OGTT
DIAGNOSTIC_TESTMRI of liverMRI of the liver and use of DIXON method

Timeline

Start date
2017-04-14
Primary completion
2018-08-29
Completion
2018-09-29
First posted
2017-02-02
Last updated
2024-04-17
Results posted
2024-04-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03041129. Inclusion in this directory is not an endorsement.