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

Adipose Tissue Angiogenesis in Polycystic Ovary Syndrome (PCOS)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01745471
Acronym
EIFFEL
Enrollment
36
Registered
2012-12-10
Start date
2012-12-06
Completion date
2025-12-31
Last updated
2025-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Diseases, Overweight, Polycystic Ovary Syndrome

Keywords

Abdominal Adipose, Gluteal Adipose, Polycystic Ovary Syndrome, Obesity, Women

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.

Interventions

None listed

Sponsors

Sanford-Burnham Medical Research Institute
CollaboratorOTHER
Pennington Biomedical Research Center
CollaboratorOTHER
Boston University
CollaboratorOTHER
Tufts University
CollaboratorOTHER
AdventHealth Translational Research Institute
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Difference of angiogenesis capacity in abdominal and gluteal adipose tissueDay 7The angiogenesis capacity of each adipose tissue depot will be determine by an in vitro angiogenesis test.

Secondary

MeasureTime frameDescription
Presence of biomarkers in abdominal and gluteal adipose tissue in obese and PCOS womenDay 7Measurement 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 tissueDay 6Adipose tissue oxygen content will be measured using the Licox CMP microprocessor.

Other

MeasureTime frameDescription
The rates of carbohydrate oxidationDay -7Resting 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.
The rates of lipid oxidationDay -7Resting 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026