Polycystic Ovary SyndromeEIFFELNCT01745471
Adipose Tissue and Polycystic Ovary Syndrome (PCOS)(EIFFEL)
An observational study of Polycystic Ovary Syndrome and Metabolic Diseases, run by AdventHealth Translational Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Metabolic Diseases, Overweight
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2012to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, 32804
About this study
Official title: 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.
Read the detailed description
Epigenetics may represent a new regulator mechanism explaining gluteal vs. abdominal fat differences.
- Conditions
- Polycystic Ovary Syndrome, Metabolic Diseases, Overweight
- Keywords
- Abdominal Adipose, Gluteal Adipose, Polycystic Ovary Syndrome, Obesity, Women
- Medical subject headings
- Polycystic Ovary Syndrome, Metabolic Diseases, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 7
Secondary outcomes (2)
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.
Measured: Day 7
Difference in oxygen content of abdominal and gluteal adipose tissue
Adipose tissue oxygen content will be measured using the Licox CMP microprocessor.
Measured: Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study start6 Dec 2012
- Primary completion4 Apr 2024
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sanford-Burnham Medical Research Institute, Pennington Biomedical Research Center, Boston University, Tufts University
- Responsible party
- Sponsor
- Investigators
- Adeline Divoux, PhD, Principal investigator, Translational Research Institute for Metabolism and DiabetesSteven R Smith, MD, Principal investigator, Translational Research Institute for Metabolism and Diabetes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745471
- Sponsor's protocol ID
- TRIMDFH 348525
- Other IDs
- 348525
- Acronym
- EIFFEL
- Status last verified
- Aug 2025
- First submitted
- 5 Dec 2012
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ehrmann DA. Polycystic ovary syndrome. N Engl J Med. 2005 Mar 24;352(12):1223-36. doi: 10.1056/NEJMra041536. No abstract available.
PubMed 15788499Weber RV, Buckley MC, Fried SK, Kral JG. Subcutaneous lipectomy causes a metabolic syndrome in hamsters. Am J Physiol Regul Integr Comp Physiol. 2000 Sep;279(3):R936-43. doi: 10.1152/ajpregu.2000.279.3.R936.
PubMed 10956251Tran TT, Yamamoto Y, Gesta S, Kahn CR. Beneficial effects of subcutaneous fat transplantation on metabolism. Cell Metab. 2008 May;7(5):410-20. doi: 10.1016/j.cmet.2008.04.004.
PubMed 18460332Elbers JM, Asscheman H, Seidell JC, Megens JA, Gooren LJ. Long-term testosterone administration increases visceral fat in female to male transsexuals. J Clin Endocrinol Metab. 1997 Jul;82(7):2044-7. doi: 10.1210/jcem.82.7.4078.
PubMed 9215270Elbers JM, Asscheman H, Seidell JC, Gooren LJ. Effects of sex steroid hormones on regional fat depots as assessed by magnetic resonance imaging in transsexuals. Am J Physiol. 1999 Feb;276(2):E317-25. doi: 10.1152/ajpendo.1999.276.2.E317.
PubMed 9950792Shi H, Seeley RJ, Clegg DJ. Sexual differences in the control of energy homeostasis. Front Neuroendocrinol. 2009 Aug;30(3):396-404. doi: 10.1016/j.yfrne.2009.03.004. Epub 2009 Mar 31.
PubMed 19341761Perrot-Sinal TS. Do these genes make me look fat? Endocrinology. 2009 Mar;150(3):1075-7. doi: 10.1210/en.2008-1586. No abstract available.
PubMed 19240263Lavebratt C, Almgren M, Ekstrom TJ. Epigenetic regulation in obesity. Int J Obes (Lond). 2012 Jun;36(6):757-65. doi: 10.1038/ijo.2011.178. Epub 2011 Sep 13.
PubMed 21912396Weisberg SP, McCann D, Desai M, Rosenbaum M, Leibel RL, Ferrante AW Jr. Obesity is associated with macrophage accumulation in adipose tissue. J Clin Invest. 2003 Dec;112(12):1796-808. doi: 10.1172/JCI19246.
PubMed 14679176Cinti S, Mitchell G, Barbatelli G, Murano I, Ceresi E, Faloia E, Wang S, Fortier M, Greenberg AS, Obin MS. Adipocyte death defines macrophage localization and function in adipose tissue of obese mice and humans. J Lipid Res. 2005 Nov;46(11):2347-55. doi: 10.1194/jlr.M500294-JLR200. Epub 2005 Sep 8.
PubMed 16150820Strissel KJ, Stancheva Z, Miyoshi H, Perfield JW 2nd, DeFuria J, Jick Z, Greenberg AS, Obin MS. Adipocyte death, adipose tissue remodeling, and obesity complications. Diabetes. 2007 Dec;56(12):2910-8. doi: 10.2337/db07-0767. Epub 2007 Sep 11.
PubMed 17848624Rogers NH, Perfield JW 2nd, Strissel KJ, Obin MS, Greenberg AS. Reduced energy expenditure and increased inflammation are early events in the development of ovariectomy-induced obesity. Endocrinology. 2009 May;150(5):2161-8. doi: 10.1210/en.2008-1405. Epub 2009 Jan 29.
PubMed 19179442Grove KL, Fried SK, Greenberg AS, Xiao XQ, Clegg DJ. A microarray analysis of sexual dimorphism of adipose tissues in high-fat-diet-induced obese mice. Int J Obes (Lond). 2010 Jun;34(6):989-1000. doi: 10.1038/ijo.2010.12. Epub 2010 Feb 16.
PubMed 20157318Sparks LM, Ukropcova B, Smith J, Pasarica M, Hymel D, Xie H, Bray GA, Miles JM, Smith SR. Relation of adipose tissue to metabolic flexibility. Diabetes Res Clin Pract. 2009 Jan;83(1):32-43. doi: 10.1016/j.diabres.2008.09.052. Epub 2008 Nov 26.
PubMed 19038471Hirosumi J, Tuncman G, Chang L, Gorgun CZ, Uysal KT, Maeda K, Karin M, Hotamisligil GS. A central role for JNK in obesity and insulin resistance. Nature. 2002 Nov 21;420(6913):333-6. doi: 10.1038/nature01137.
PubMed 12447443
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose Tissue Angiogenesis in Polycystic Ovary Syndrome (PCOS)
- ClinicalTrials.gov ID
- NCT01745471
- Acronym / sponsor ID
- EIFFEL / TRIMDFH 348525
- Conditions
- Polycystic Ovary Syndrome, Metabolic Diseases, Overweight
- Keywords
- Abdominal Adipose, Gluteal Adipose, Polycystic Ovary Syndrome, Obesity, Women
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Collaborators
- Sanford-Burnham Medical Research Institute, Pennington Biomedical Research Center, Boston University, Tufts University
- Study start
- 6 Dec 2012 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Epigenetics may represent a new regulator mechanism explaining gluteal vs. abdominal fat differences.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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 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.
Key inclusion criteria (6 listed)
- 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
- NIH criteria - confirmed by subjects' medical records.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference of angiogenesis capacity in abdominal and gluteal adipose tissue
Time frame: Day 7
The angiogenesis capacity of each adipose tissue depot will be determine by an in vitro angiogenesis test.
2 secondary outcomes
Presence of biomarkers in abdominal and gluteal adipose tissue in obese and PCOS women
Time frame: Day 7
Difference in oxygen content of abdominal and gluteal adipose tissue
Time frame: Day 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Background: PubMed 15788499Ehrmann DA. Polycystic ovary syndrome. N Engl J Med. 2005 Mar 24;352(12):1223-36. doi: 10.1056/NEJMra041536. No abstract available.
- Background: PubMed 10956251Weber RV, Buckley MC, Fried SK, Kral JG. Subcutaneous lipectomy causes a metabolic syndrome in hamsters. Am J Physiol Regul Integr Comp Physiol. 2000 Sep;279(3):R936-43. doi: 10.1152/ajpregu.2000.279.3.R936.
- Background: PubMed 18460332Tran TT, Yamamoto Y, Gesta S, Kahn CR. Beneficial effects of subcutaneous fat transplantation on metabolism. Cell Metab. 2008 May;7(5):410-20. doi: 10.1016/j.cmet.2008.04.004.
- Background: PubMed 9215270Elbers JM, Asscheman H, Seidell JC, Megens JA, Gooren LJ. Long-term testosterone administration increases visceral fat in female to male transsexuals. J Clin Endocrinol Metab. 1997 Jul;82(7):2044-7. doi: 10.1210/jcem.82.7.4078.
- Background: PubMed 9950792Elbers JM, Asscheman H, Seidell JC, Gooren LJ. Effects of sex steroid hormones on regional fat depots as assessed by magnetic resonance imaging in transsexuals. Am J Physiol. 1999 Feb;276(2):E317-25. doi: 10.1152/ajpendo.1999.276.2.E317.
- Background: PubMed 19341761Shi H, Seeley RJ, Clegg DJ. Sexual differences in the control of energy homeostasis. Front Neuroendocrinol. 2009 Aug;30(3):396-404. doi: 10.1016/j.yfrne.2009.03.004. Epub 2009 Mar 31.
- Background: PubMed 19240263Perrot-Sinal TS. Do these genes make me look fat? Endocrinology. 2009 Mar;150(3):1075-7. doi: 10.1210/en.2008-1586. No abstract available.
- Background: PubMed 21912396Lavebratt C, Almgren M, Ekstrom TJ. Epigenetic regulation in obesity. Int J Obes (Lond). 2012 Jun;36(6):757-65. doi: 10.1038/ijo.2011.178. Epub 2011 Sep 13.
- Background: PubMed 14679176Weisberg SP, McCann D, Desai M, Rosenbaum M, Leibel RL, Ferrante AW Jr. Obesity is associated with macrophage accumulation in adipose tissue. J Clin Invest. 2003 Dec;112(12):1796-808. doi: 10.1172/JCI19246.
- Background: PubMed 16150820Cinti S, Mitchell G, Barbatelli G, Murano I, Ceresi E, Faloia E, Wang S, Fortier M, Greenberg AS, Obin MS. Adipocyte death defines macrophage localization and function in adipose tissue of obese mice and humans. J Lipid Res. 2005 Nov;46(11):2347-55. doi: 10.1194/jlr.M500294-JLR200. Epub 2005 Sep 8.
- Background: PubMed 17848624Strissel KJ, Stancheva Z, Miyoshi H, Perfield JW 2nd, DeFuria J, Jick Z, Greenberg AS, Obin MS. Adipocyte death, adipose tissue remodeling, and obesity complications. Diabetes. 2007 Dec;56(12):2910-8. doi: 10.2337/db07-0767. Epub 2007 Sep 11.
- Background: PubMed 19179442Rogers NH, Perfield JW 2nd, Strissel KJ, Obin MS, Greenberg AS. Reduced energy expenditure and increased inflammation are early events in the development of ovariectomy-induced obesity. Endocrinology. 2009 May;150(5):2161-8. doi: 10.1210/en.2008-1405. Epub 2009 Jan 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adeline Divoux, PhD principal investigator
Translational Research Institute for Metabolism and Diabetes
Steven R Smith, MD principal investigator
Translational Research Institute for Metabolism and Diabetes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome and Metabolic Diseases, run by AdventHealth Translational Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of angiogenesis capacity in abdominal and gluteal adipose tissue (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01745471, which also lists 47 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.