Adipose Tissue and Polycystic Ovary Syndrome (PCOS)(EIFFEL)
This trial is active, not recruiting.
|Conditions||polycystic ovary syndrome, metabolic diseases, overweight|
|Sponsor||Translational Research Institute for Metabolism and Diabetes, Florida|
|Collaborator||Sanford-Burnham Medical Research Institute|
|Start date||December 2012|
|End date||December 2014|
|Trial size||36 participants|
|Trial identifier||NCT01745471, 348525, TRIMDFH 348525|
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.
|Observational model||case control|
12 women with Polycystic Ovary Syndrome (PCOS) as defined by NIH criteria
12 with an android pattern as defined by a waist-to-hip greater than 0.85
12 will have a gynoid pattern as defined by a waist-to-hip ratio less than 0.78
Difference of angiogenesis capacity in abdominal and gluteal adipose tissue
time frame: Day 7
Presence of biomarkers in abdominal and gluteal adipose tissue in obese and PCOS women
time frame: Day 7
Difference in oxygen content of abdominal and gluteal adipose tissue
time frame: Day 6
Female participants from 20 years up to 40 years old.
- 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.
- 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.
|Official title||Adipose Tissue Angiogenesis in Polycystic Ovary Syndrome (PCOS)|
|Principal investigator||Adeline Divoux, PhD|
|Description||Epigenetics may represent a new regulator mechanism explaining gluteal vs. abdominal fat differences.|
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