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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 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: April 22, 2014
Last verified: April 2014
  Purpose

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.


Condition
Polycystic Ovary Syndrome
Metabolic Diseases
Overweight

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Adipose Tissue Angiogenesis in Polycystic Ovary Syndrome (PCOS)

Resource links provided by NLM:


Further study details as provided by Translational Research Institute for Metabolism and Diabetes, Florida:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.



Biospecimen Retention:   Samples With DNA

Blood Urine Adipose tissue


Estimated Enrollment: 36
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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's 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.

Criteria

Inclusion Criteria:

  • Female
  • Age > 20 and < 40
  • Weight stable (change of less than 3 kg in the last 8 weeks), and within 10% of peak body weight (not including pregnancy).
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745471

Contacts
Contact: Celines Martinez 407-303-7100 tri@flhosp.org

Locations
United States, Florida
Translational Research Institute for Metabolism and Diabetes Recruiting
Orlando, Florida, United States, 32804
Contact: Celines Martinez    407-303-7100    tri@flhosp.org   
Principal Investigator: Adeline Divoux, PhD         
Principal Investigator: Steven R Smith, MD         
Sub-Investigator: Julie Clyatt, ARNP         
Sub-Investigator: Richard E Pratley, MD         
Sponsors and Collaborators
Translational Research Institute for Metabolism and Diabetes, Florida
Sanford-Burnham Medical Research Institute
Pennington Biomedical Research Center
Boston University
Tufts University
Investigators
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
  More Information

Additional Information:
Publications:

Responsible Party: Translational Research Institute for Metabolism and Diabetes, Florida
ClinicalTrials.gov Identifier: NCT01745471     History of Changes
Other Study ID Numbers: TRIMDFH 348525, 348525
Study First Received: December 5, 2012
Last Updated: April 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Translational Research Institute for Metabolism and Diabetes, Florida:
Abdominal Adipose
Gluteal Adipose
Polycystic Ovary Syndrome
Obesity
Women

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Metabolic Diseases
Overweight
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014