Adipose Tissue and Polycystic Ovary Syndrome (PCOS)(EIFFEL)
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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) |
- 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.
- 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.
- 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 2013 |
| Estimated Primary Completion Date: | December 2013 (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 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.
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 > 30 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| Contact: Sheila Brock | (407) 303-7193 |
| United States, Florida | |
| Translational Research Institute for Metabolism and Diabetes | Recruiting |
| Orlando, Florida, United States, 32804 | |
| Contact: Sheila Brock 407-303-7193 Sheila.Brock@FLHosp.org | |
| Principal Investigator: Adeline Divoux, PhD | |
| Principal Investigator: Steven R Smith, MD | |
| Sub-Investigator: Julie Clyatt, ARNP | |
| Sub-Investigator: Richard E Pratley, MD | |
| 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: | January 4, 2013 |
| 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:
|
Metabolic Diseases Polycystic Ovary Syndrome 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 May 23, 2013