Post-Prandial Liver Glucose Metabolism in PCOS

NCT03041129 | Completed Results

• 1 other identifier: 16-2399
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovarian Syndrome; Obesity; Hepatic Steatosis

Keywords

hepatic de novo lipogenesis

Outcome Measures

Primary Outcomes (1)

• 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 up to 4 months from enrollment

Secondary Outcomes (5)

• Hepatic Metabolism Ratios

  Measured up to 4 months from enrollment

• Whole Body Insulin Sensitivity

  Measured up to 4 months from enrollment

• Sleep Duration

  Measured up to 4 months from enrollment

• Sleep Quality

  Measured up to 4 months from enrollment

• Hepatic Phosphate Concentrations

  Measured up to 4 months from enrollment

Study Arms (4)

Untreated PCOS

PCOS per NIH criteria. Obese Lifestyle treatment only.

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.

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.

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

Diagnostic Test: oral glucose tolerance test; Diagnostic Test: MRI of liver

Interventions

oral glucose tolerance test DIAGNOSTIC_TEST

6 hours OGTT

Metformin PCOS-(Study arm not funded); Obese Control group-(Study arm not funded); Oral Contraceptive PCOS-(Study arm not funded); Untreated PCOS

MRI of liver DIAGNOSTIC_TEST

MRI of the liver and use of DIXON method

Metformin PCOS-(Study arm not funded); Obese Control group-(Study arm not funded); Oral Contraceptive PCOS-(Study arm not funded); Untreated PCOS

Eligibility Criteria

• Age: 12 Years - 21 Years
• Gender Eligibility Details: Females only
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Girls age 12-21. Obese \>90th percentile for BMI for age.

You may qualify if:

• 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.

You may not qualify if:

• 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 \<84 lbs.
• Anemia, defined as Hemoglobin \< 10 mg/dL
• Diagnosed major psychiatric or developmental disorder limiting informed consent

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anshutz Medical Campus/Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Carreau 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 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA for hepatic steatosis related genes

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Obesity; Fatty Liver

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Limitations and Caveats

Due to the Covid-19 outbreak, and lack of funding we were unable to enroll the participants in the metformin arm, oral contraceptive arm, and the obese control group. Only enrolled participants in untreated PCOS group.

Results Point of Contact

• Title: Melanie Cree-Green, PI
• Organization: University of Colorado

melanie.green@childrenscolorado.org

720-777-5743

Study Officials

• Melanie Cree-Green, MD, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 2, 2017
• Study Start: April 14, 2017
• Primary Completion: August 29, 2018
• Study Completion: September 29, 2018
• Last Updated: April 17, 2024
• Results First Posted: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)