Polycystic Ovarian SyndromePLUMNCT03041129
Post-Prandial Liver Glucose Metabolism in PCOS
An observational study of Polycystic Ovarian Syndrome and Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovarian Syndrome, Obesity, Hepatic Steatosis
- What is being tested?
- oral glucose tolerance test and MRI of liver
- Type of treatment
- Pill or oral medicine
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2017to 29 Sep 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Girls age 12-21. Obese >90th percentile for BMI for age.
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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 <84 lbs.
- Anemia, defined as Hemoglobin < 10 mg/dL
- Diagnosed major psychiatric or developmental disorder limiting informed consent
- Implanted metal devices that are not compatible with MRI
- Use of blood pressure medications
- Known liver disease other than NAFLD or AST or ALT >150 mg/mL
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anshutz Medical Campus/Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Post-Prandial Liver Glucose Metabolism in Polycystic Ovarian Syndrome (PCOS) and Understanding Standard of Care Medications
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.
Read the 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
- Polycystic Ovarian Syndrome, Obesity, Hepatic Steatosis
- Being tested
- oral glucose tolerance test, MRI of liver
- Keywords
- hepatic de novo lipogenesis
- Medical subject headings
- Polycystic Ovary Syndrome, Obesity, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral glucose tolerance testDiagnostic test
6 hours OGTT
MRI of liverDiagnostic test
MRI of the liver and use of DIXON method
| Study group | Role | What they receive |
|---|---|---|
| Untreated PCOS | PCOS per NIH criteria. Obese Lifestyle treatment only. Receives: Diagnostic Test: oral glucose tolerance test; Diagnostic Test: MRI of liver | |
| Metformin PCOS-(Study arm not funded) | PCOS per NIH criteria. Obese Taking 1500 mg of metformin or more per day for at least 6 months. Receives: Diagnostic Test: oral glucose tolerance test; Diagnostic Test: MRI of liver | |
| Oral Contraceptive PCOS-(Study arm not funded) | PCOS per NIH criteria. Obese Taking 30 mcg of ethanyl estradiol or more per day for at least 6 months. Receives: Diagnostic Test: oral glucose tolerance test; Diagnostic Test: MRI of liver | |
| Obese Control group-(Study arm not funded) | Obese Regular menses at least 18 months post-menarche Females only Receives: Diagnostic Test: oral glucose tolerance test; Diagnostic Test: MRI of liver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic Fat Fraction
Amount of fat in the liver measured by MRI and calculated via the Dixon method as the proton density hepatic fat fraction, which ranges from 0-75%. Greater than 5% is considered extra fat in the liver.
Measured: Measured up to 4 months from enrollment
Secondary outcomes (5)
Hepatic Metabolism Ratios
Percent indirect glucose at 360 minutes following an oral sugar tolerance test (OGTT) with an isotope labeled oral glycerol tracer.
Measured: Measured up to 4 months from enrollment
Whole Body Insulin Sensitivity
Participants will undergo a 75 gram oral glucose tolerance test, and whole body insulin sensitivity will be expressed as Si, calculated via the oral minimal model.
Measured: Measured up to 4 months from enrollment
Sleep Duration
Sleep duration will be assessed using home actigraphy using the Philips Actigraph wrist-worn watch, and collects 7 days of data.
Measured: Measured up to 4 months from enrollment
Sleep Quality
Apnea Hypopnea Index (AHI) will be measured using WatchPAT. The higher the AHI, indicates more severe sleep apnea.
The AHI is the number of times you have apnea or hypopnea during one night, divided by the hours of sleep.
Normal sleep: An AHI of fewer than five events, on average, per hour Mild sleep apnea: An AHI of five to 14 events per hour Moderate sleep apnea: An AHI of 15 to 29 events per hour Severe sleep apnea: An AHI of 30 or more events per hour
Measured: Measured up to 4 months from enrollment
Hepatic Phosphate Concentrations
31 phosphorus spectroscopy will be utilized to measure hepatic Phosphodiesterase (PDE)/Total phosphate concentration. This is measured in the MRI using a phosphorus coil.
Measured: Measured up to 4 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start14 Apr 2017
- Primary completion29 Aug 2018
- Study completion29 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovarian SyndromeStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melanie Cree-Green, MD, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041129
- Sponsor's protocol ID
- 16-2399
- Acronym
- PLUM
- Status last verified
- Apr 2024
- First submitted
- 31 Jan 2017
- Last updated
- 17 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boster 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.
PubMed 42014131Carreau 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.
PubMed 31301251
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Prandial Liver Glucose Metabolism in Polycystic Ovarian Syndrome (PCOS) and Understanding Standard of Care Medications
- ClinicalTrials.gov ID
- NCT03041129
- Acronym / sponsor ID
- PLUM / 16-2399
- Conditions
- Polycystic Ovarian Syndrome, Obesity, Hepatic Steatosis
- Keywords
- hepatic de novo lipogenesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 14 Apr 2017 (actual)
- Primary completion
- 29 Aug 2018 (actual)
- Study completion
- 29 Sep 2018 (actual)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Posted 17 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Untreated PCOS | – | Diagnostic Test: oral glucose tolerance test, Diagnostic Test: MRI of liverPCOS per NIH criteria. Obese Lifestyle treatment only. |
| Metformin PCOS-(Study arm not funded) | – | Diagnostic Test: oral glucose tolerance test, Diagnostic Test: MRI of liverPCOS per NIH criteria. Obese Taking 1500 mg of metformin or more per day for at least 6 months. |
| Oral Contraceptive PCOS-(Study arm not funded) | – | Diagnostic Test: oral glucose tolerance test, Diagnostic Test: MRI of liverPCOS per NIH criteria. Obese Taking 30 mcg of ethanyl estradiol or more per day for at least 6 months. |
| Obese Control group-(Study arm not funded) | – | Diagnostic Test: oral glucose tolerance test, Diagnostic Test: MRI of liverObese Regular menses at least 18 months post-menarche Females only |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Girls age 12-21. Obese >90th percentile for BMI for age.
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (19 listed)
- Use of medications known to affect insulin sensitivity:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral glucose tolerance test6 hours OGTT | Diagnostic test | Metformin PCOS-(Study arm not funded), Obese Control group-(Study arm not funded), Oral Contraceptive PCOS-(Study arm not funded), Untreated PCOS |
| MRI of liverMRI of the liver and use of DIXON method | Diagnostic test | Metformin PCOS-(Study arm not funded), Obese Control group-(Study arm not funded), Oral Contraceptive PCOS-(Study arm not funded), Untreated PCOS |
Primary outcome
Hepatic Fat Fraction
Time frame: Measured up to 4 months from enrollment
Amount of fat in the liver measured by MRI and calculated via the Dixon method as the proton density hepatic fat fraction, which ranges from 0-75%. Greater than 5% is considered extra fat in the liver.
5 secondary outcomes
Hepatic Metabolism Ratios
Time frame: Measured up to 4 months from enrollment
Whole Body Insulin Sensitivity
Time frame: Measured up to 4 months from enrollment
Sleep Duration
Time frame: Measured up to 4 months from enrollment
Sleep Quality
Time frame: Measured up to 4 months from enrollment
Hepatic Phosphate Concentrations
Time frame: Measured up to 4 months from enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42014131Boster 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.
- Derived from this study: PubMed 31301251Carreau 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie Cree-Green, MD, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovarian Syndrome and Obesity, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic Fat Fraction (time frame: Measured up to 4 months from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03041129, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.