Clinical trial · Observational
Post-Prandial Liver Glucose Metabolism in PCOS
Post-Prandial Liver Glucose Metabolism in Polycystic Ovarian Syndrome (PCOS) and Understanding Standard of Care Medications
NCT03041129CI-TRIAL-00076130PLUMcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatic Steatosis | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
| Polycystic Ovarian Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI of liver | Diagnostic Test | — | UNRESOLVED |
| oral glucose tolerance test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Untreated PCOS
- description
- PCOS per NIH criteria. Obese Lifestyle treatment only.
- interventionNames
- Diagnostic Test: oral glucose tolerance test
- Diagnostic Test: MRI of liver
- label
- Metformin PCOS-(Study arm not funded)
- description
- PCOS per NIH criteria. Obese Taking 1500 mg of metformin or more per day for at least 6 months.
- interventionNames
- Diagnostic Test: oral glucose tolerance test
- Diagnostic Test: MRI of liver
- label
- Oral Contraceptive PCOS-(Study arm not funded)
- description
- PCOS per NIH criteria. Obese Taking 30 mcg of ethanyl estradiol or more per day for at least 6 months.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 12 Years
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria:
1. Female
2. Ages 12-21
3. Sedentary- less than 2.5 hours of moderate (jogging, swimming etc) exercise a week.
4. BMI equal or greater than the 90th percentile for age and gender
5. 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.
6. 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.
7. For non-PCOS groups:
* regular menstrual cycles at least 1.5 years after menarche, and
* no clinical evidence of hyperandrogenism.
Exclusion Criteria:
1. 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.
2. Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study.
3. Severe illness requiring hospitalization within 60 days
4. Diabetes, defined as Hemoglobin A1C \> 6.4%
5. BMI percentile less than the 90th percentile for age and sex.
6. Weight \>325 lbs or \<84 lbs.
7. Anemia, defined as Hemoglobin \< 10 mg/dL
8. Diagnosed major psychiatric or developmental disorder limiting informed consent
9. Implanted metal devices that are not compatible with MRI
10. Use of blood pressure medications
11. Known liver disease other than NAFLD or AST or ALT \>150 mg/mL
\-References
Publications (2)
- DERIVEDBoster JM, Cree MG, Kelsey MM, Nadeau KJ, Chaidez A, Pan Z, Sundaram SS. Relative Skeletal Muscle Mass Is Associated With Hepatic Steatosis in Adolescents With Overweight and Obesity. Pediatr Obes. 2026 Apr;21(4):e70108. doi: 10.1111/ijpo.70108. PMID 42014131
- DERIVEDCarreau AM, Pyle L, Garcia-Reyes Y, Rahat H, Vigers T, Jensen T, Scherzinger A, Nadeau KJ, Cree-Green M. Clinical prediction score of nonalcoholic fatty liver disease in adolescent girls with polycystic ovary syndrome (PCOS-HS index). Clin Endocrinol (Oxf). 2019 Oct;91(4):544-552. doi: 10.1111/cen.14062. Epub 2019 Aug 16. PMID 31301251