Clinical trial · Observational
Adipose Tissue and Polycystic Ovary Syndrome (PCOS)(EIFFEL)
Adipose Tissue Angiogenesis in Polycystic Ovary Syndrome (PCOS)
NCT01745471CI-TRIAL-00093034EIFFELactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metabolic Diseases | — | UNRESOLVED | — |
| Overweight | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- PCOS group
- description
- 12 women with Polycystic Ovary Syndrome (PCOS) as defined by NIH criteria
- label
- Pear shapes
- description
- 12 with an android pattern as defined by a waist-to-hip greater than 0.85
- label
- Apple shapes
- description
- 12 will have a gynoid pattern as defined by a waist-to-hip ratio less than 0.78
Primary outcomes (1)
- measure
- Difference of angiogenesis capacity in abdominal and gluteal adipose tissue
- timeFrame
- Day 7
- description
- The angiogenesis capacity of each adipose tissue depot will be determine by an in vitro angiogenesis test.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (47)
- BACKGROUNDEhrmann DA. Polycystic ovary syndrome. N Engl J Med. 2005 Mar 24;352(12):1223-36. doi: 10.1056/NEJMra041536. No abstract available. PMID 15788499
- BACKGROUNDWeber 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. PMID 10956251
- BACKGROUNDTran 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. PMID 18460332
- BACKGROUNDElbers 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. PMID 9215270
- BACKGROUNDElbers 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. PMID 9950792
- BACKGROUNDShi 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. PMID 19341761
- BACKGROUNDPerrot-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. PMID 19240263
- BACKGROUNDLavebratt 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.