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

Overweight Clinical Trial

— EIFFEL  

Official title:

Adipose Tissue Angiogenesis in Polycystic Ovary Syndrome (PCOS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01745471
• Other study ID #: TRIMDFH 348525
• Secondary ID: 348525
• Status: Active, not recruiting
• Start date: December 6, 2012
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: AdventHealth Translational Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: June 2024
• Est. primary completion date: February 3, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Diseases
• Overweight
• Polycystic Ovary Syndrome
• Syndrome

Locations

Country	Name	City	State
United States	Translational Research Institute for Metabolism and Diabetes	Orlando	Florida

Sponsors (5)

Lead Sponsor	Collaborator
AdventHealth Translational Research Institute	Boston University, Pennington Biomedical Research Center, Sanford-Burnham Medical Research Institute, Tufts University

Country where clinical trial is conducted

United States, 

References & Publications (45)

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* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The rates of carbohydrate oxidation	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.	Day -7
Other	The rates of lipid oxidation	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.	Day -7
Primary	Difference of angiogenesis capacity in abdominal and gluteal adipose tissue	The angiogenesis capacity of each adipose tissue depot will be determine by an in vitro angiogenesis test.	Day 7
Secondary	Presence of biomarkers in abdominal and gluteal adipose tissue in obese and PCOS women	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.	Day 7
Secondary	Difference in oxygen content of abdominal and gluteal adipose tissue	Adipose tissue oxygen content will be measured using the Licox CMP microprocessor.	Day 6

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