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

A

AdventHealth Translational Research Institute

Status

Active, not recruiting

Conditions

Metabolic Diseases
Overweight
Polycystic Ovary Syndrome

Study type

Observational

Funder types

Other

Identifiers

NCT01745471
TRIMDFH 348525
348525 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment

36 estimated patients

Sex

Female

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

36 participants in 3 patient groups

PCOS group
Description:
12 women with Polycystic Ovary Syndrome (PCOS) as defined by NIH criteria
Pear shapes
Description:
12 with an android pattern as defined by a waist-to-hip greater than 0.85
Apple shapes
Description:
12 will have a gynoid pattern as defined by a waist-to-hip ratio less than 0.78

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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