Transcriptional and Epigenetic Program of PCOS Women (EPIC)

March 12, 2025 updated by: AdventHealth Translational Research Institute
The main goal is to reveal differences in global gene expression in two different adipose tissue (AT) depots of females with and without polycystic ovary syndrome (PCOS) and how these are influenced by upstream epigenetic markers

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • AdventHealth Translational Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Recruitment methods utilized may include, but will not be limited to, the following: recruitment from within the AdventHealth Translational Research Institute's patient population: electronic medical records and database searches (including third party recruitment vendors); advertising in multiple media such as print ads, flyers, brochures, posters; radio ads; television spots; and internet/social media advertising.

Description

Inclusion Criteria:

  1. Women;
  2. Age 18-45 years inclusive;
  3. BMI 23-40 kg/m2 inclusive;
  4. HbA1C ≤ 6.0% or fasting plasma glucose < 126 mg/dL;
  5. Weight stable (± 3 kg) during the 3 months prior to enrollment;
  6. Women must be > 9 months post-partum;
  7. For PCOS: A documented history of PCOS from their physician according to the Androgen Excess (AE)-PCOS criteria: (defined by the presence of hyperandrogenism (clinical and/or biochemical), ovarian dysfunction (oligo-anovulation and/or polycystic ovaries), and the exclusion of related disorders (eg. hypoadrenalism, ovarian tumors)
  8. Regular menstrual cycle for females without PCOS
  9. Able to provide written, informed consent.

Exclusion Criteria:

  1. Postmenopausal women
  2. Women with hysterectomy
  3. Pregnancy, lactation or < 9 months postpartum from the scheduled date of screening.
  4. Fasting plasma glucose > 126 mg/dL, or HbA1c > 6% or diagnosis with Type 2 Diabetes (T2D) or Type 1 Diabetes (T1D)
  5. History or presence of cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months, clinically significant abnormalities on EKG), presence of cardiac pacemaker, implanted cardiac defibrillator.
  6. Liver disease (AST or ALT >2.5 times the upper limit of normal)
  7. Kidney disease (creatinine >1.6 mg/dl or estimated GFR <60 ml/min)
  8. Dyslipidemia, including triglycerides >500 mg/dl, LDL >200 mg/dl
  9. Anemia (hemoglobin <11 g/dl)
  10. Thyroid dysfunction (suppressed thyroid-stimulating hormone, elevated TSH <10 µIU/ml if symptomatic or elevated TSH >10 µIU/ml if asymptomatic)
  11. Uncontrolled hypertension (BP >160 mmHg systolic or >100 mmHg diastolic)
  12. Elevated hsCRP or known active infection
  13. History of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable)
  14. History of drug or alcohol abuse (> 3 drinks per day) within the last 5 years. Current drug use may be determined by plasma or urine drug screens.
  15. psychiatric disease prohibiting adherence to study protocol.
  16. History of organ transplant.
  17. Known history of HIV, active Hepatitis A, B or C or tuberculosis.
  18. History of bariatric surgery.
  19. Current smokers (smoking within the past 3 months).
  20. Current use of beta-adrenergic blocking agents.
  21. Use of oral or injectable anti-hyperglycemic agents: metformin, sulfonylureas, DPP IV inhibitors, SGLT-2 inhibitors, thiazolidinediones, acarbose, GLP-1 analogs and insulin unless willing to undertake a washout period of 15 days for metformin and GLP-1 analogs and undergo subsequent laboratory screening tests.
  22. Gonadotropin Releasing Hormone (GnRH) and/or Antiandrogen use within the last 2 months.
  23. Use of any medications known to influence fat and/or energy metabolism (eg growth hormone therapy, glucocorticoids [steroids], etc.)
  24. Initiation or change in hormone replacement therapy within the past 3 months (including, but not limited to thyroid hormone, estrogen replacement therapy or In Vitro Fertilization therapy).
  25. Current treatment with blood thinners or antiplatelet medications that cannot be safely stopped for biopsy and testing procedures.
  26. Not able or willing to have DXA scans or are above the acceptable weight limit (450 lbs) of the DXA scanner.
  27. Presence of any condition that, in the opinion of the Investigators, compromises participant safety or data integrity or the participant's ability to complete study visits.

  28. Not able to participate in MRI assessments due to:

    1. Metal implants (pacemaker, non-removable body piercings, aneurysm clips) based on Investigator's judgment at screening
    2. Physical limitations or equipment tolerances (e.g., MRI bore size) based on Investigator's judgment at screening
    3. Inability to tolerate MRI imaging without sedation or claustrophobia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PCOS females
Females diagnosed with PCOS with a BMI between 23 and 40 kg/m2.
Other: DEXA
DEXA Scans will be performed to measure body fat and estimate muscle mass using a General Electric Lunar iDXA whole-body scanner.
Other: Magnetic Resonance (MR) Assessment of the Abdomen
Include measures to assess liver lipid content and stiffness and perform volumetric fat quantitation.
Other: MR assessment of Whole Body Fat
Volumetric measurement of fat, muscle and bone
Procedure: Adipose tissue biopsy
0.5 cm incision of the upper-outer right vastus lateralis, and either a 3-4mm Mercedes Liposuction needle, or a 4-6 mm Bergstrom needle will be inserted to aspirate approximately 7 grams of adipose tissue.
Other: Oral glucose tolerance test
Glucose tolerance will be assessed with a 75 g oral glucose tolerance test (OGTT). Subjects will be studied after an overnight fast.
Non-PCOS control females
Females without PCOS with a BMI between 23 and 40 kg/m2 split into 2 groups- apple shaped and pear shaped.
Other: DEXA
DEXA Scans will be performed to measure body fat and estimate muscle mass using a General Electric Lunar iDXA whole-body scanner.
Other: Magnetic Resonance (MR) Assessment of the Abdomen
Include measures to assess liver lipid content and stiffness and perform volumetric fat quantitation.
Other: MR assessment of Whole Body Fat
Volumetric measurement of fat, muscle and bone
Procedure: Adipose tissue biopsy
0.5 cm incision of the upper-outer right vastus lateralis, and either a 3-4mm Mercedes Liposuction needle, or a 4-6 mm Bergstrom needle will be inserted to aspirate approximately 7 grams of adipose tissue.
Other: Oral glucose tolerance test
Glucose tolerance will be assessed with a 75 g oral glucose tolerance test (OGTT). Subjects will be studied after an overnight fast.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epigenomic and transcriptomic differences in abdominal vs gluteal subcutaneous adipose tissue between females with and without polycystic ovary syndrome
Time Frame: 6 months after the last participant will be enrolled
Epigenetic profiles (DNA methylation) and gene expression (RNA-seq) will be performed on whole tissue abdominal fat and gluteofemoral fat biopsies in addition to cultured pre-adipocytes and adipocytes.
6 months after the last participant will be enrolled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth Translational Research Institute

Investigators

  • Principal Investigator: Steven Smith, MD, Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2020

Primary Completion (Actual)

April 12, 2023

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 24, 2019

First Submitted That Met QC Criteria

July 24, 2019

First Posted (Actual)

July 26, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 12, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 1354588

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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