Adipose Tissue and Polycystic Ovary Syndrome (PCOS)(EIFFEL) (EIFFEL)

August 1, 2025 updated by: AdventHealth Translational Research Institute

Adipose Tissue Angiogenesis in Polycystic Ovary Syndrome (PCOS)

The purpose of this study is to collect data to help understand why some women develop Polycystic Ovary Syndrome (PCOS) associated with decreased lower-body fat.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Epigenetics may represent a new regulator mechanism explaining gluteal vs. abdominal fat differences.

Study Type

Observational

Enrollment (Estimated)

36

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
        • Translational Research Institute for Metabolism and Diabetes

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Study Population and screening: Healthy young women with a BMI > 30 will be recruited; 12 will have a gynoid pattern as defined by a waist-to-hip ratio less than 0.78 and 12 with an android pattern as defined by a waist-to-hip greater than 0.85. A third group will include 12 women with PCOS as defined by the NIH criteria. Subjects will be recruited via a dedicated website, physician referrals, direct mail outs, newspaper advertisements, and brochures. Only subjects that will sign informed consent and meet eligibility criteria will be enrolled in this study.

Description

Inclusion Criteria:

  • Female
  • Age > 20 and < 40
  • Weight stable (change of less than 3 kg in the last 8 weeks)
  • BMI < 40 kg/m2 or > 27 kg/m2

Supplemental inclusion criteria for PCOS women:

  • NIH criteria - confirmed by subjects' medical records.

Exclusion Criteria:

  • Male
  • Women who are pregnant or lactating (breast feeding)
  • Post-menopausal women
  • Women with hysterectomy
  • Diagnosed with diabetes, or have a fasting blood sugar > 126 mg/dL.
  • Untreated or symptomatic thyroid disease.
  • Impaired kidney or liver function, as evidenced by your blood work
  • Hypertension/ high blood pressure or are taking blood pressure medications
  • Use of oral contraceptives or hormone replacement therapy.
  • History of drug or alcohol abuse (> 3 drinks per day) in the last 5 years, or psychiatric disease prohibiting adherence to study protocol.
  • History of cancer within the last 5 years.
  • History of organ transplant.
  • History of HIV, active Hepatitis B or C, or Tuberculosis.
  • History of heart attack/ myocardial infarction.
  • Presence of clinically significant abnormalities on EKG.
  • Current smokers (smoking within the past 3 months)
  • Use of any medications known to influence glucose, fat and/or energy metabolism within the last 3 months (e.g., growth hormone therapy, glucocorticoids [steroids], etc.). Metformin for women with PCOS is allowed.

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: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
PCOS group
12 women with Polycystic Ovary Syndrome (PCOS) as defined by NIH criteria
Pear shapes
12 with an android pattern as defined by a waist-to-hip greater than 0.85
Apple shapes
12 will have a gynoid pattern as defined by a waist-to-hip ratio less than 0.78

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of angiogenesis capacity in abdominal and gluteal adipose tissue
Time Frame: Day 7
The angiogenesis capacity of each adipose tissue depot will be determine by an in vitro angiogenesis test.
Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of biomarkers in abdominal and gluteal adipose tissue in obese and PCOS women
Time Frame: Day 7

Measurement will be obtained with Fluorescence-activated cell sorting (FACS).

Identify different and similar biomarkers in obese and PCOS women, from abdominal and gluteal adipose tissue samples. Total RNA, micro RNA and DNA will be extracted from each type of cells using FACS-cell sorting analysis.
Day 7
Difference in oxygen content of abdominal and gluteal adipose tissue
Time Frame: Day 6
Adipose tissue oxygen content will be measured using the Licox CMP microprocessor.
Day 6

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rates of carbohydrate oxidation
Time Frame: Day -7

Resting Metabolic Rate (RMR) will measure the resting metabolic rate/respiratory quotient (RMR/RQ) and substrate utilization.

Energy expenditure and respiratory quotient standardized for temperature, pressure, and moisture will be calculated at one-minute intervals, over 30 minutes.
Day -7
The rates of lipid oxidation
Time Frame: Day -7

Resting Metabolic Rate (RMR) will measure the resting metabolic rate/respiratory quotient (RMR/RQ) and substrate utilization.

Energy expenditure and respiratory quotient standardized for temperature, pressure, and moisture will be calculated at one-minute intervals, over 30 minutes.
Day -7

Collaborators and Investigators

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

Sponsor

AdventHealth Translational Research Institute

Collaborators

Boston University
Tufts University
Pennington Biomedical Research Center
Sanford-Burnham Medical Research Institute

Investigators

  • Principal Investigator: Adeline Divoux, PhD, Translational Research Institute for Metabolism and Diabetes
  • Principal Investigator: Steven R Smith, MD, Translational Research Institute for Metabolism and Diabetes

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)

December 6, 2012

Primary Completion (Actual)

April 4, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 5, 2012

First Submitted That Met QC Criteria

December 6, 2012

First Posted (Estimated)

December 10, 2012

Study Record Updates

Last Update Posted (Actual)

August 3, 2025

Last Update Submitted That Met QC Criteria

August 1, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIMDFH 348525
  • 348525 (Other Identifier: AdventHealth)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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