COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post-Prandial Liver Glucose Metabolism in PCOS (PLUM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03041129
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief 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.

Condition or disease Intervention/treatment
Polycystic Ovarian Syndrome Obesity Hepatic Steatosis Diagnostic Test: oral glucose tolerance test Diagnostic Test: MRI of liver

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Post-Prandial Liver Glucose Metabolism in Polycystic Ovarian Syndrome (PCOS) and Understanding Standard of Care Medications
Actual Study Start Date : April 14, 2017
Actual Primary Completion Date : August 29, 2018
Actual Study Completion Date : September 29, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Group/Cohort Intervention/treatment
Untreated PCOS
PCOS per NIH criteria. Obese Lifestyle treatment only.
Diagnostic Test: oral glucose tolerance test
6 hours OGTT

Diagnostic Test: MRI of liver
MRI of the liver and use of DIXON method

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.
Diagnostic Test: oral glucose tolerance test
6 hours OGTT

Diagnostic Test: MRI of liver
MRI of the liver and use of DIXON method

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.
Diagnostic Test: oral glucose tolerance test
6 hours OGTT

Diagnostic Test: MRI of liver
MRI of the liver and use of DIXON method

Obese Control group-(Study arm not funded)
Obese Regular menses at least 18 months post-menarche Females only
Diagnostic Test: oral glucose tolerance test
6 hours OGTT

Diagnostic Test: MRI of liver
MRI of the liver and use of DIXON method




Primary Outcome Measures :
  1. Hepatic fat fraction [ Time Frame: Within 4 months from Screening Visit ]
    Amount of fat in the liver


Secondary Outcome Measures :
  1. Hepatic metabolism ratios [ Time Frame: Within 4 months from Screening Visit ]
    Ratio of pentose phosphate pathway, TCA cycle and fatty acid synthesis metabolites following an OGTT

  2. Whole Body Insulin Sensitivity [ Time Frame: Within 4 months from Screening Visit ]
    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.

  3. Sleep duration [ Time Frame: Within 4 months from Screening Visit ]
    Sleep duration will be assessed using home actigraphy

  4. Sleep quality [ Time Frame: Within 4 months from Screening Visit ]
    Apnea Hypopnea Index (AHI) will be measured using WatchPAT. In children and adolescents the scale that will be used is AHI>5 is considered mild sleep apnea. The higher the AHI, indicates more severe sleep apnea.

  5. Stool microbiome profile [ Time Frame: Within 4 months from Screening Visit ]
    Stool microbiome profiles will be determined

  6. Hepatic phosphate concentrations [ Time Frame: Within 4 months from Screening Visit ]
    31 phosphorus spectroscopy will be utilized to measure hepatic phosphate concentrations


Biospecimen Retention:   Samples With DNA
DNA for hepatic steatosis related genes


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females only
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Girls age 12-21. Obese >90th percentile for BMI for age.
Criteria

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

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041129


Locations
Layout table for location information
United States, Colorado
University of Colorado Anshutz Medical Campus/Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Layout table for investigator information
Principal Investigator: Melanie Cree-Green, MD, PhD University of Colorado, Denver
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03041129    
Other Study ID Numbers: 16-2399
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
hepatic de novo lipogenesis
Additional relevant MeSH terms:
Layout table for MeSH terms
Polycystic Ovary Syndrome
Fatty Liver
Syndrome
Disease
Pathologic Processes
Liver Diseases
Digestive System Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases