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

Sponsor

AdventHealth Translational Research Institute (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01745471

Collaborator

Sanford-Burnham Medical Research Institute (Other), Pennington Biomedical Research Center (Other), Boston University (Other), Tufts University (Other)

Enrollment

Location

119.8

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome Metabolic Diseases Overweight

Detailed Description

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

36 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Adipose Tissue Angiogenesis in Polycystic Ovary Syndrome (PCOS)

Actual Study Start Date :

Dec 6, 2012

Actual Primary Completion Date :

Feb 3, 2015

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Difference of angiogenesis capacity in abdominal and gluteal adipose tissue [Day 7]
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 [Day 7]
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 [Day 6]
Adipose tissue oxygen content will be measured using the Licox CMP microprocessor.

Other Outcome Measures

The rates of carbohydrate oxidation [Day -7]
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 [Day -7]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Translational Research Institute for Metabolism and Diabetes	Orlando	Florida	United States	32804

Sponsors and Collaborators

AdventHealth Translational Research Institute
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