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

Active, not recruiting

• Conditions: Overweight; Metabolic Diseases; Polycystic Ovary Syndrome

• Registration Number: NCT01745471
• Lead Sponsor: AdventHealth Translational Research Institute

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2012-12-05
• Study Start: 2012-12-06
• Study First Submitted QC: 2012-12-06
• Study First Posted: 2012-12-10
• Primary Completion: 2015-02-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-13
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 36

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference of angiogenesis capacity in abdominal and gluteal adipose tissue	Day 7	The angiogenesis capacity of each adipose tissue depot will be determine by an in vitro angiogenesis test.

Secondary Outcome Measures

Name	Time	Method
Presence of biomarkers in abdominal and gluteal adipose tissue in obese and PCOS women	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.
Difference in oxygen content of abdominal and gluteal adipose tissue	Day 6	Adipose tissue oxygen content will be measured using the Licox CMP microprocessor.

Trial Locations

Locations (1)

Translational Research Institute for Metabolism and Diabetes; 🇺🇸 Orlando, Florida, United States