N/A
N=19
Post-Prandial Liver Glucose Metabolism in PCOS
Polycystic Ovarian Syndrome · Obesity · Hepatic Steatosis
Bottom Line
View on ClinicalTrials.gov: NCT03041129 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Hepatic Fat Fraction — 8.35 Percent
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- oral glucose tolerance test (Diagnostic_test); MRI of liver (Diagnostic_test)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- Female
- Sponsor
- University of Colorado, Denver
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hepatic Fat Fraction |
8.35 | — |
| SECONDARY Hepatic Metabolism Ratios |
22.1 | — |
| SECONDARY Whole Body Insulin Sensitivity |
0.000278106 | — |
| SECONDARY Sleep Duration |
443.44 | — |
| SECONDARY Sleep Quality |
19.66 | — |
| SECONDARY Hepatic Phosphate Concentrations |
23 | — |
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.
Eligibility Criteria
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:
- (NIH definition) irregular menstrual cycles at least 1.5 years after menarche, and
- either clinical evidence of hyperandogenism, or
- elevated Testosterone (above the norms for age/tanner stage) at time of screening, or documented prior to initiation of therapy for OCP and metformin groups.
- For PCOS groups:
- patients un-treated or currently treated with either Metformin 1500-2000 mg a day, or
- oral contraception (30-35 mcg ethynyl estradiol a day) for at least 6 months, with > 80% adherence confirmed via refill frequency from pharmacy.
- For non-PCOS groups:
- regular menstrual cycles at least 1.5 years after menarche, and
- no clinical evidence of hyperandrogenism.
Exclusion Criteria
- Use of medications known to affect insulin sensitivity:
- oral glucocorticoids within 10 days,
- atypical antipsychotics,
- immunosuppressant agents,
- HIV medications.
- Nexplanon, Depo-Provera or Mirena progesterone only contraceptives.
- Dermal patch or vaginal ring contraception methods.
- For controls only: metformin or oral contraception.
- 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 150 mg/mL
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Data sourced from ClinicalTrials.gov (NCT03041129). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.