Clinical trial NCT01745471: Adipose Tissue and Polycystic Ovary Syndrome (PCOS)(EIFFEL)
Official title: Adipose Tissue Angiogenesis in Polycystic Ovary Syndrome (PCOS)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Polycystic Ovary Syndrome
Metabolic Diseases
Overweight
Keywords: Abdominal Adipose
Gluteal Adipose
Polycystic Ovary Syndrome
Obesity
Women
Lead sponsor: AdventHealth Translational Research Institute
Sponsor class: OTHER
Collaborators: name: Sanford-Burnham Medical Research Institute
name: Pennington Biomedical Research Center
name: Boston University
name: Tufts University
First posted: 2012-12-10
Enrollment: 36
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study Population and screening: Healthy young women with a BMI \> 30 will be recruited; 12 will have a gynoid pattern as defined by a waist-to-hip ratio less than 0.78 and 12 with an android pattern as defined by a waist-to-hip greater than 0.85. A third group will include 12 women with PCOS as defined by the NIH criteria. Subjects will be recruited via a dedicated website, physician referrals, direct mail outs, newspaper advertisements, and brochures. Only subjects that will sign informed consent and meet eligibility criteria will be enrolled in this study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Difference of angiogenesis capacity in abdominal and gluteal adipose tissue
timeFrame: Day 7
Secondary outcomes:
measure: Presence of biomarkers in abdominal and gluteal adipose tissue in obese and PCOS women
timeFrame: Day 7
measure: Difference in oxygen content of abdominal and gluteal adipose tissue
timeFrame: Day 6
Other outcomes:
measure: The rates of carbohydrate oxidation
timeFrame: Day -7
measure: The rates of lipid oxidation
timeFrame: Day -7
Locations:
city: Orlando
country: United States
facility: Translational Research Institute for Metabolism and Diabetes
state: Florida
Study officials:
affiliation: Translational Research Institute for Metabolism and Diabetes
name: Adeline Divoux, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Translational Research Institute for Metabolism and Diabetes
name: Steven R Smith, MD
role: PRINCIPAL_INVESTIGATOR
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