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NCT Number: NCT01745471

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

AdventHealth Translational Research Institute

Other

Collaborators

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

Registry information

Official study title

Adipose Tissue Angiogenesis in Polycystic Ovary Syndrome (PCOS)

Acronym: EIFFEL

Important dates

Study start
2012
Primary completion
2024
Study completion
2025
First posted
Dec 10, 2012
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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