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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Translational Research Institute for Metabolism and Diabetes, Florida
Sponsor:
Collaborators:
Sanford-Burnham Medical Research Institute
Pennington Biomedical Research Center
Boston University
Tufts University
Information provided by (Responsible Party):
Translational Research Institute for Metabolism and Diabetes, Florida
ClinicalTrials.gov Identifier:
NCT01745471
First received: December 5, 2012
Last updated: October 22, 2014
Last verified: October 2014

December 5, 2012
October 22, 2014
December 2012
December 2014   (final data collection date for primary outcome measure)
Difference of angiogenesis capacity in abdominal and gluteal adipose tissue [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
The angiogenesis capacity of each adipose tissue depot will be determine by an in vitro angiogenesis test.
Same as current
Complete list of historical versions of study NCT01745471 on ClinicalTrials.gov Archive Site
  • Presence of biomarkers in abdominal and gluteal adipose tissue in obese and PCOS women [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

    Measurement 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 tissue [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
    Adipose tissue oxygen content will be measured using the Licox CMP microprocessor.
Same as current
  • The rates of carbohydrate oxidation [ Time Frame: Day -7 ] [ Designated as safety issue: No ]

    Resting 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 oxidation [ Time Frame: Day -7 ] [ Designated as safety issue: No ]

    Resting 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.

Same as current
 
Adipose Tissue and Polycystic Ovary Syndrome (PCOS)(EIFFEL)
Adipose Tissue Angiogenesis in Polycystic Ovary Syndrome (PCOS)

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.

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

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood Urine Adipose tissue

Probability Sample

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.

  • Polycystic Ovary Syndrome
  • Metabolic Diseases
  • Overweight
Not Provided
  • PCOS group
    12 women with Polycystic Ovary Syndrome (PCOS) as defined by NIH criteria
  • Pear shapes
    12 with an android pattern as defined by a waist-to-hip greater than 0.85
  • Apple shapes
    12 will have a gynoid pattern as defined by a waist-to-hip ratio less than 0.78

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
December 2014
December 2014   (final data collection date for primary outcome measure)

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&apos; 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.
Female
20 Years to 40 Years
Yes
Contact: Celines Martinez 407-303-7100 tri@flhosp.org
United States
 
NCT01745471
TRIMDFH 348525, 348525
Yes
Translational Research Institute for Metabolism and Diabetes, Florida
Translational Research Institute for Metabolism and Diabetes, Florida
  • Sanford-Burnham Medical Research Institute
  • Pennington Biomedical Research Center
  • Boston University
  • Tufts University
Principal Investigator: Adeline Divoux, PhD Translational Research Institute for Metabolism and Diabetes
Principal Investigator: Steven R Smith, MD Translational Research Institute for Metabolism and Diabetes
Translational Research Institute for Metabolism and Diabetes, Florida
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP