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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
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

Primary Outcomes

Difference of angiogenesis capacity in abdominal and gluteal adipose tissue
time frame: Day 7

Secondary Outcomes

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

Eligibility Criteria

Female participants from 20 years up to 40 years old.

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Translational Research Institute for Metabolism and Diabetes, Florida.