Home
Clinical Trials
Adipose Tissue and Polycystic...

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

Last Updated: 2025-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-06

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Adipose Tissue Gene Expression Profiles in Women With Polycystic Ovary Syndrome (PCOS) Versus Controls

NCT01195142

Polycystic Ovary Syndrome

COMPLETED

REFUEL PCOS Study 1

NCT05973175

Polycystic Ovary Syndrome

RECRUITING

Adipose Expression of Leptin, Adiponectin and IL-6 and Plasma Levels of Adipocytokines in Women With and Without Polycystic Ovary Syndrome (PCOS)

NCT01088061

Polycystic Ovary Syndrome

COMPLETED

Transcriptional and Epigenetic Program of PCOS Women

NCT04034706

PCOS

ACTIVE_NOT_RECRUITING

Adipocytokines and Polycystic Ovary Syndrome (PCOS)

NCT00975832

Polycystic Ovary Syndrome

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Polycystic Ovary Syndrome Metabolic Diseases Overweight

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PCOS group

12 women with Polycystic Ovary Syndrome (PCOS) as defined by NIH criteria

No interventions assigned to this group

Pear shapes

12 with an android pattern as defined by a waist-to-hip greater than 0.85

No interventions assigned to this group

Apple shapes

12 will have a gynoid pattern as defined by a waist-to-hip ratio less than 0.78

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Adeline Divoux, PhD

Role: PRINCIPAL_INVESTIGATOR

Translational Research Institute for Metabolism and Diabetes

Steven R Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Translational Research Institute for Metabolism and Diabetes

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Ehrmann DA. Polycystic ovary syndrome. N Engl J Med. 2005 Mar 24;352(12):1223-36. doi: 10.1056/NEJMra041536. No abstract available.

Reference Type BACKGROUND

PMID: 15788499 (View on PubMed)

Weber 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.

Reference Type BACKGROUND

PMID: 10956251 (View on PubMed)

Tran 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.

Reference Type BACKGROUND

PMID: 18460332 (View on PubMed)

Elbers 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.

Reference Type BACKGROUND

PMID: 9215270 (View on PubMed)

Elbers 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.

Reference Type BACKGROUND

PMID: 9950792 (View on PubMed)

Shi 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.

Reference Type BACKGROUND

PMID: 19341761 (View on PubMed)

Perrot-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.

Reference Type BACKGROUND

PMID: 19240263 (View on PubMed)

Lavebratt 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.

Reference Type BACKGROUND

PMID: 21912396 (View on PubMed)

Weisberg 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.

Reference Type BACKGROUND

PMID: 14679176 (View on PubMed)

Cinti 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.

Reference Type BACKGROUND

PMID: 16150820 (View on PubMed)

Strissel 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.

Reference Type BACKGROUND

PMID: 17848624 (View on PubMed)

Rogers 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.

Reference Type BACKGROUND

PMID: 19179442 (View on PubMed)

Grove 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.

Reference Type BACKGROUND

PMID: 20157318 (View on PubMed)

Sparks 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.

Reference Type BACKGROUND

PMID: 19038471 (View on PubMed)

Hirosumi 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.

Reference Type BACKGROUND

PMID: 12447443 (View on PubMed)

Hotamisligil GS, Murray DL, Choy LN, Spiegelman BM. Tumor necrosis factor alpha inhibits signaling from the insulin receptor. Proc Natl Acad Sci U S A. 1994 May 24;91(11):4854-8. doi: 10.1073/pnas.91.11.4854.

Reference Type BACKGROUND

PMID: 8197147 (View on PubMed)

Arkan MC, Hevener AL, Greten FR, Maeda S, Li ZW, Long JM, Wynshaw-Boris A, Poli G, Olefsky J, Karin M. IKK-beta links inflammation to obesity-induced insulin resistance. Nat Med. 2005 Feb;11(2):191-8. doi: 10.1038/nm1185. Epub 2005 Jan 30.

Reference Type BACKGROUND

PMID: 15685170 (View on PubMed)

Macotela Y, Boucher J, Tran TT, Kahn CR. Sex and depot differences in adipocyte insulin sensitivity and glucose metabolism. Diabetes. 2009 Apr;58(4):803-12. doi: 10.2337/db08-1054. Epub 2009 Jan 9.

Reference Type BACKGROUND

PMID: 19136652 (View on PubMed)

Guerre-Millo M, Leturque A, Girard J, Lavau M. Increased insulin sensitivity and responsiveness of glucose metabolism in adipocytes from female versus male rats. J Clin Invest. 1985 Jul;76(1):109-16. doi: 10.1172/JCI111932.

Reference Type BACKGROUND

PMID: 3894416 (View on PubMed)

D'Eon TM, Souza SC, Aronovitz M, Obin MS, Fried SK, Greenberg AS. Estrogen regulation of adiposity and fuel partitioning. Evidence of genomic and non-genomic regulation of lipogenic and oxidative pathways. J Biol Chem. 2005 Oct 28;280(43):35983-91. doi: 10.1074/jbc.M507339200. Epub 2005 Aug 17.

Reference Type BACKGROUND

PMID: 16109719 (View on PubMed)

Riant E, Waget A, Cogo H, Arnal JF, Burcelin R, Gourdy P. Estrogens protect against high-fat diet-induced insulin resistance and glucose intolerance in mice. Endocrinology. 2009 May;150(5):2109-17. doi: 10.1210/en.2008-0971. Epub 2009 Jan 22.

Reference Type BACKGROUND

PMID: 19164473 (View on PubMed)

Gao H, Bryzgalova G, Hedman E, Khan A, Efendic S, Gustafsson JA, Dahlman-Wright K. Long-term administration of estradiol decreases expression of hepatic lipogenic genes and improves insulin sensitivity in ob/ob mice: a possible mechanism is through direct regulation of signal transducer and activator of transcription 3. Mol Endocrinol. 2006 Jun;20(6):1287-99. doi: 10.1210/me.2006-0012. Epub 2006 Apr 20.

Reference Type BACKGROUND

PMID: 16627594 (View on PubMed)

Pasarica M, Sereda OR, Redman LM, Albarado DC, Hymel DT, Roan LE, Rood JC, Burk DH, Smith SR. Reduced adipose tissue oxygenation in human obesity: evidence for rarefaction, macrophage chemotaxis, and inflammation without an angiogenic response. Diabetes. 2009 Mar;58(3):718-25. doi: 10.2337/db08-1098. Epub 2008 Dec 15.

Reference Type BACKGROUND

PMID: 19074987 (View on PubMed)

Khan T, Muise ES, Iyengar P, Wang ZV, Chandalia M, Abate N, Zhang BB, Bonaldo P, Chua S, Scherer PE. Metabolic dysregulation and adipose tissue fibrosis: role of collagen VI. Mol Cell Biol. 2009 Mar;29(6):1575-91. doi: 10.1128/MCB.01300-08. Epub 2008 Dec 29.

Reference Type BACKGROUND

PMID: 19114551 (View on PubMed)

Haas E, Bhattacharya I, Brailoiu E, Damjanovic M, Brailoiu GC, Gao X, Mueller-Guerre L, Marjon NA, Gut A, Minotti R, Meyer MR, Amann K, Ammann E, Perez-Dominguez A, Genoni M, Clegg DJ, Dun NJ, Resta TC, Prossnitz ER, Barton M. Regulatory role of G protein-coupled estrogen receptor for vascular function and obesity. Circ Res. 2009 Feb 13;104(3):288-91. doi: 10.1161/CIRCRESAHA.108.190892. Epub 2009 Jan 29.

Reference Type BACKGROUND

PMID: 19179659 (View on PubMed)

Belanger C, Luu-The V, Dupont P, Tchernof A. Adipose tissue intracrinology: potential importance of local androgen/estrogen metabolism in the regulation of adiposity. Horm Metab Res. 2002 Nov-Dec;34(11-12):737-45. doi: 10.1055/s-2002-38265.

Reference Type BACKGROUND

PMID: 12660892 (View on PubMed)

Cleland WH, Mendelson CR, Simpson ER. Aromatase activity of membrane fractions of human adipose tissue stromal cells and adipocytes. Endocrinology. 1983 Dec;113(6):2155-60. doi: 10.1210/endo-113-6-2155.

Reference Type BACKGROUND

PMID: 6641629 (View on PubMed)

Brasaemle DL, Dolios G, Shapiro L, Wang R. Proteomic analysis of proteins associated with lipid droplets of basal and lipolytically stimulated 3T3-L1 adipocytes. J Biol Chem. 2004 Nov 5;279(45):46835-42. doi: 10.1074/jbc.M409340200. Epub 2004 Aug 27.

Reference Type BACKGROUND

PMID: 15337753 (View on PubMed)

Khor VK, Tong MH, Qian Y, Song WC. Gender-specific expression and mechanism of regulation of estrogen sulfotransferase in adipose tissues of the mouse. Endocrinology. 2008 Nov;149(11):5440-8. doi: 10.1210/en.2008-0271. Epub 2008 Jul 31.

Reference Type BACKGROUND

PMID: 18669602 (View on PubMed)

Marin P, Krotkiewski M, Bjorntorp P. Androgen treatment of middle-aged, obese men: effects on metabolism, muscle and adipose tissues. Eur J Med. 1992 Oct;1(6):329-36.

Reference Type BACKGROUND

PMID: 1341460 (View on PubMed)

Lovejoy JC, Champagne CM, de Jonge L, Xie H, Smith SR. Increased visceral fat and decreased energy expenditure during the menopausal transition. Int J Obes (Lond). 2008 Jun;32(6):949-58. doi: 10.1038/ijo.2008.25. Epub 2008 Mar 11.

Reference Type BACKGROUND

PMID: 18332882 (View on PubMed)

van Nas A, Guhathakurta D, Wang SS, Yehya N, Horvath S, Zhang B, Ingram-Drake L, Chaudhuri G, Schadt EE, Drake TA, Arnold AP, Lusis AJ. Elucidating the role of gonadal hormones in sexually dimorphic gene coexpression networks. Endocrinology. 2009 Mar;150(3):1235-49. doi: 10.1210/en.2008-0563. Epub 2008 Oct 30.

Reference Type BACKGROUND

PMID: 18974276 (View on PubMed)

Guo K, Mogen J, Struzzi S, Zhang Y. Preadipocyte transplantation: an in vivo study of direct leptin signaling on adipocyte morphogenesis and cell size. Am J Physiol Regul Integr Comp Physiol. 2009 May;296(5):R1339-47. doi: 10.1152/ajpregu.90691.2008. Epub 2009 Feb 4.

Reference Type BACKGROUND

PMID: 19193947 (View on PubMed)

Fabian MR, Sonenberg N, Filipowicz W. Regulation of mRNA translation and stability by microRNAs. Annu Rev Biochem. 2010;79:351-79. doi: 10.1146/annurev-biochem-060308-103103.

Reference Type BACKGROUND

PMID: 20533884 (View on PubMed)

Jones ME, Thorburn AW, Britt KL, Hewitt KN, Wreford NG, Proietto J, Oz OK, Leury BJ, Robertson KM, Yao S, Simpson ER. Aromatase-deficient (ArKO) mice have a phenotype of increased adiposity. Proc Natl Acad Sci U S A. 2000 Nov 7;97(23):12735-40. doi: 10.1073/pnas.97.23.12735.

Reference Type BACKGROUND

PMID: 11070087 (View on PubMed)

Friso S, Choi SW, Dolnikowski GG, Selhub J. A method to assess genomic DNA methylation using high-performance liquid chromatography/electrospray ionization mass spectrometry. Anal Chem. 2002 Sep 1;74(17):4526-31. doi: 10.1021/ac020050h.

Reference Type BACKGROUND

PMID: 12236365 (View on PubMed)

Elia M, Livesey G. Energy expenditure and fuel selection in biological systems: the theory and practice of calculations based on indirect calorimetry and tracer methods. World Rev Nutr Diet. 1992;70:68-131. doi: 10.1159/000421672. No abstract available.

Reference Type BACKGROUND

PMID: 1292242 (View on PubMed)

Freda PU, Shen W, Reyes-Vidal CM, Geer EB, Arias-Mendoza F, Gallagher D, Heymsfield SB. Skeletal muscle mass in acromegaly assessed by magnetic resonance imaging and dual-photon x-ray absorptiometry. J Clin Endocrinol Metab. 2009 Aug;94(8):2880-6. doi: 10.1210/jc.2009-0026. Epub 2009 Jun 2.

Reference Type BACKGROUND

PMID: 19491226 (View on PubMed)

Livingstone MB, Black AE. Markers of the validity of reported energy intake. J Nutr. 2003 Mar;133 Suppl 3:895S-920S. doi: 10.1093/jn/133.3.895S.

Reference Type BACKGROUND

PMID: 12612176 (View on PubMed)

Schoeller DA, Racette SB. A review of field techniques for the assessment of energy expenditure. J Nutr. 1990 Nov;120 Suppl 11(11 Suppl):1492-5. doi: 10.1093/jn/120.suppl_11.1492.

Reference Type BACKGROUND

PMID: 2243294 (View on PubMed)

Gealekman O, Guseva N, Hartigan C, Apotheker S, Gorgoglione M, Gurav K, Tran KV, Straubhaar J, Nicoloro S, Czech MP, Thompson M, Perugini RA, Corvera S. Depot-specific differences and insufficient subcutaneous adipose tissue angiogenesis in human obesity. Circulation. 2011 Jan 18;123(2):186-94. doi: 10.1161/CIRCULATIONAHA.110.970145. Epub 2011 Jan 3.

Reference Type BACKGROUND

PMID: 21200001 (View on PubMed)

Lavau M, Susini C, Knittle J, Blanchet-Hirst S, Greenwood MR. A reliable photomicrographic method to determining fat cell size and number: application to dietary obesity. Proc Soc Exp Biol Med. 1977 Nov;156(2):251-6. doi: 10.3181/00379727-156-39916. No abstract available.

Reference Type BACKGROUND

PMID: 928396 (View on PubMed)

Adams V, Lenk K, Linke A, Lenz D, Erbs S, Sandri M, Tarnok A, Gielen S, Emmrich F, Schuler G, Hambrecht R. Increase of circulating endothelial progenitor cells in patients with coronary artery disease after exercise-induced ischemia. Arterioscler Thromb Vasc Biol. 2004 Apr;24(4):684-90. doi: 10.1161/01.ATV.0000124104.23702.a0. Epub 2004 Feb 26.

Reference Type BACKGROUND

PMID: 14988094 (View on PubMed)

Chironi G, Walch L, Pernollet MG, Gariepy J, Levenson J, Rendu F, Simon A. Decreased number of circulating CD34+KDR+ cells in asymptomatic subjects with preclinical atherosclerosis. Atherosclerosis. 2007 Mar;191(1):115-20. doi: 10.1016/j.atherosclerosis.2006.02.041. Epub 2006 Apr 18.

Reference Type BACKGROUND

PMID: 16620831 (View on PubMed)

Van Craenenbroeck EM, Conraads VM, Van Bockstaele DR, Haine SE, Vermeulen K, Van Tendeloo VF, Vrints CJ, Hoymans VY. Quantification of circulating endothelial progenitor cells: a methodological comparison of six flow cytometric approaches. J Immunol Methods. 2008 Mar 20;332(1-2):31-40. doi: 10.1016/j.jim.2007.12.006. Epub 2008 Jan 18.

Reference Type BACKGROUND

PMID: 18255093 (View on PubMed)

Divoux A, Sandor K, Bojcsuk D, Talukder A, Li X, Balint BL, Osborne TF, Smith SR. Differential open chromatin profile and transcriptomic signature define depot-specific human subcutaneous preadipocytes: primary outcomes. Clin Epigenetics. 2018 Nov 26;10(1):148. doi: 10.1186/s13148-018-0582-0.

Reference Type DERIVED

PMID: 30477572 (View on PubMed)

Divoux A, Xie H, Li JL, Karastergiou K, Perera RJ, Chang RJ, Fried SK, Smith SR. MicroRNA-196 Regulates HOX Gene Expression in Human Gluteal Adipose Tissue. Obesity (Silver Spring). 2017 Aug;25(8):1375-1383. doi: 10.1002/oby.21896. Epub 2017 Jun 25.

Reference Type DERIVED

PMID: 28649807 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

348525

Identifier Type: OTHER

Identifier Source: secondary_id

TRIMDFH 348525

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Comparison of Lifestyle Markers Between Women With and Without Polycystic Ovary Syndrome

NCT01859663 COMPLETED

PolyCystic Ovary Syndrome as Suggested Risk Group for Non-Alcoholic Fatty Liver Disease

NCT07146815 COMPLETED NA

The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome

NCT07342946 NOT_YET_RECRUITING NA

Risk of Coronary Heart Disease in Women With Polycystic Ovary Syndrome

NCT00005459 COMPLETED

Molecular Basis of PCOS in Oocytes and Surrounding Cells

NCT04493788 UNKNOWN

Environmental Factors in the Development of Polycystic Ovary Syndrome

NCT00341731 COMPLETED

Correlating Improvement in PCOS Symptoms to the Percentage of Body Weight Lost in Females Also Living With Obesity

NCT06325449 NOT_YET_RECRUITING NA

Epicardial Adipose Tissue Thickness in Polycystic Ovary Syndrome (PCOS)

NCT01258946 COMPLETED

The RolE oF Androgen Excess in MUscle Energy MetaboLism in Women With PolyCystic Ovary Syndrome (REFUEL PCOS) Study 2

NCT05647356 UNKNOWN NA

Prevalence of Polycystic Ovary Syndrome (PCOS) in Obese Premenopausal Women

NCT01319162 COMPLETED

Pro-vascular Regenerative Cell Exhaustion in Women With Polycystic Ovarian Syndrome

NCT05410834 UNKNOWN

Metabolic Disturbances in Polycystic Ovary Syndrome (PCOS)

NCT00606671 COMPLETED

Serum Metabolomics Study of Polycystic Ovary Syndrome

NCT03618342 UNKNOWN

Weight Loss Intervention in Women With PCOS

NCT03677362 COMPLETED NA

Effect of Weight & Insulin Sensitivity on Reproductive Function in PCOS: Studies in Skeletal Muscle & Adipose

NCT01775176 TERMINATED

Effect of Dietary Fiber Intervention on Patients With Polycystic Ovary Syndrome

NCT05431816 UNKNOWN NA

Non-alcoholic Fatty Liver Disease in Women With Polycystic Ovary Syndrome

NCT05843955 COMPLETED

Post-Prandial Liver Glucose Metabolism in PCOS

NCT03041129 COMPLETED

Evaluation of Ovarian Morphology and Function in Overweight Women During Weight Loss

NCT01785719 COMPLETED NA

Ovarian Ultrasonography for the Clinical Evaluation of Polycystic Ovary Syndrome

NCT03547453 COMPLETED

Transcriptomic Profile of Adipose Tissue Following n-3 Polyunsaturated Fatty Acid (PUFA) Supplementation

NCT01195155 COMPLETED NA

Reflexology's Effect on Polycystic Ovary Syndrome (PCOS)

NCT00744510 UNKNOWN PHASE3

Nutritional and Metabolic Correlates of Ovarian Morphology in Women With Polycystic Ovary Syndrome

NCT01927471 COMPLETED

Compromised Microcirculation in Women With Polycystic Ovary Syndrome

NCT00757185 COMPLETED EARLY_PHASE1

Effects of Exercise for Overweight Women With Polycystic Ovary Syndrome

NCT01150539 COMPLETED NA

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

Study Results

Basic Information

Brief Summary

Related Clinical Trials

Adipose Tissue Gene Expression Profiles in Women With Polycystic Ovary Syndrome (PCOS) Versus Controls

REFUEL PCOS Study 1

Adipose Expression of Leptin, Adiponectin and IL-6 and Plasma Levels of Adipocytokines in Women With and Without Polycystic Ovary Syndrome (PCOS)

Transcriptional and Epigenetic Program of PCOS Women

Adipocytokines and Polycystic Ovary Syndrome (PCOS)

Detailed Description

Conditions

Study Design

Study Groups

PCOS group

Pear shapes

Apple shapes

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Sanford-Burnham Medical Research Institute

Pennington Biomedical Research Center

Boston University

Tufts University

AdventHealth Translational Research Institute

Responsible Party

Principal Investigators

Adeline Divoux, PhD

Steven R Smith, MD

Locations

Translational Research Institute for Metabolism and Diabetes

Countries

References

Ehrmann DA. Polycystic ovary syndrome. N Engl J Med. 2005 Mar 24;352(12):1223-36. doi: 10.1056/NEJMra041536. No abstract available.

Weber 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.

Tran 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.

Elbers 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.

Elbers 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.

Shi 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.

Perrot-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.

Lavebratt 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.

Weisberg 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.

Cinti 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.

Strissel 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.

Rogers 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.

Grove 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.

Sparks 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.

Hirosumi 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.

Hotamisligil GS, Murray DL, Choy LN, Spiegelman BM. Tumor necrosis factor alpha inhibits signaling from the insulin receptor. Proc Natl Acad Sci U S A. 1994 May 24;91(11):4854-8. doi: 10.1073/pnas.91.11.4854.

Arkan MC, Hevener AL, Greten FR, Maeda S, Li ZW, Long JM, Wynshaw-Boris A, Poli G, Olefsky J, Karin M. IKK-beta links inflammation to obesity-induced insulin resistance. Nat Med. 2005 Feb;11(2):191-8. doi: 10.1038/nm1185. Epub 2005 Jan 30.

Macotela Y, Boucher J, Tran TT, Kahn CR. Sex and depot differences in adipocyte insulin sensitivity and glucose metabolism. Diabetes. 2009 Apr;58(4):803-12. doi: 10.2337/db08-1054. Epub 2009 Jan 9.

Guerre-Millo M, Leturque A, Girard J, Lavau M. Increased insulin sensitivity and responsiveness of glucose metabolism in adipocytes from female versus male rats. J Clin Invest. 1985 Jul;76(1):109-16. doi: 10.1172/JCI111932.

D'Eon TM, Souza SC, Aronovitz M, Obin MS, Fried SK, Greenberg AS. Estrogen regulation of adiposity and fuel partitioning. Evidence of genomic and non-genomic regulation of lipogenic and oxidative pathways. J Biol Chem. 2005 Oct 28;280(43):35983-91. doi: 10.1074/jbc.M507339200. Epub 2005 Aug 17.

Riant E, Waget A, Cogo H, Arnal JF, Burcelin R, Gourdy P. Estrogens protect against high-fat diet-induced insulin resistance and glucose intolerance in mice. Endocrinology. 2009 May;150(5):2109-17. doi: 10.1210/en.2008-0971. Epub 2009 Jan 22.

Khan T, Muise ES, Iyengar P, Wang ZV, Chandalia M, Abate N, Zhang BB, Bonaldo P, Chua S, Scherer PE. Metabolic dysregulation and adipose tissue fibrosis: role of collagen VI. Mol Cell Biol. 2009 Mar;29(6):1575-91. doi: 10.1128/MCB.01300-08. Epub 2008 Dec 29.

Belanger C, Luu-The V, Dupont P, Tchernof A. Adipose tissue intracrinology: potential importance of local androgen/estrogen metabolism in the regulation of adiposity. Horm Metab Res. 2002 Nov-Dec;34(11-12):737-45. doi: 10.1055/s-2002-38265.

Cleland WH, Mendelson CR, Simpson ER. Aromatase activity of membrane fractions of human adipose tissue stromal cells and adipocytes. Endocrinology. 1983 Dec;113(6):2155-60. doi: 10.1210/endo-113-6-2155.

Brasaemle DL, Dolios G, Shapiro L, Wang R. Proteomic analysis of proteins associated with lipid droplets of basal and lipolytically stimulated 3T3-L1 adipocytes. J Biol Chem. 2004 Nov 5;279(45):46835-42. doi: 10.1074/jbc.M409340200. Epub 2004 Aug 27.

Khor VK, Tong MH, Qian Y, Song WC. Gender-specific expression and mechanism of regulation of estrogen sulfotransferase in adipose tissues of the mouse. Endocrinology. 2008 Nov;149(11):5440-8. doi: 10.1210/en.2008-0271. Epub 2008 Jul 31.

Marin P, Krotkiewski M, Bjorntorp P. Androgen treatment of middle-aged, obese men: effects on metabolism, muscle and adipose tissues. Eur J Med. 1992 Oct;1(6):329-36.

Lovejoy JC, Champagne CM, de Jonge L, Xie H, Smith SR. Increased visceral fat and decreased energy expenditure during the menopausal transition. Int J Obes (Lond). 2008 Jun;32(6):949-58. doi: 10.1038/ijo.2008.25. Epub 2008 Mar 11.

Guo K, Mogen J, Struzzi S, Zhang Y. Preadipocyte transplantation: an in vivo study of direct leptin signaling on adipocyte morphogenesis and cell size. Am J Physiol Regul Integr Comp Physiol. 2009 May;296(5):R1339-47. doi: 10.1152/ajpregu.90691.2008. Epub 2009 Feb 4.

Fabian MR, Sonenberg N, Filipowicz W. Regulation of mRNA translation and stability by microRNAs. Annu Rev Biochem. 2010;79:351-79. doi: 10.1146/annurev-biochem-060308-103103.

Jones ME, Thorburn AW, Britt KL, Hewitt KN, Wreford NG, Proietto J, Oz OK, Leury BJ, Robertson KM, Yao S, Simpson ER. Aromatase-deficient (ArKO) mice have a phenotype of increased adiposity. Proc Natl Acad Sci U S A. 2000 Nov 7;97(23):12735-40. doi: 10.1073/pnas.97.23.12735.

Friso S, Choi SW, Dolnikowski GG, Selhub J. A method to assess genomic DNA methylation using high-performance liquid chromatography/electrospray ionization mass spectrometry. Anal Chem. 2002 Sep 1;74(17):4526-31. doi: 10.1021/ac020050h.

Elia M, Livesey G. Energy expenditure and fuel selection in biological systems: the theory and practice of calculations based on indirect calorimetry and tracer methods. World Rev Nutr Diet. 1992;70:68-131. doi: 10.1159/000421672. No abstract available.

Freda PU, Shen W, Reyes-Vidal CM, Geer EB, Arias-Mendoza F, Gallagher D, Heymsfield SB. Skeletal muscle mass in acromegaly assessed by magnetic resonance imaging and dual-photon x-ray absorptiometry. J Clin Endocrinol Metab. 2009 Aug;94(8):2880-6. doi: 10.1210/jc.2009-0026. Epub 2009 Jun 2.

Livingstone MB, Black AE. Markers of the validity of reported energy intake. J Nutr. 2003 Mar;133 Suppl 3:895S-920S. doi: 10.1093/jn/133.3.895S.

Schoeller DA, Racette SB. A review of field techniques for the assessment of energy expenditure. J Nutr. 1990 Nov;120 Suppl 11(11 Suppl):1492-5. doi: 10.1093/jn/120.suppl_11.1492.

Lavau M, Susini C, Knittle J, Blanchet-Hirst S, Greenwood MR. A reliable photomicrographic method to determining fat cell size and number: application to dietary obesity. Proc Soc Exp Biol Med. 1977 Nov;156(2):251-6. doi: 10.3181/00379727-156-39916. No abstract available.

Chironi G, Walch L, Pernollet MG, Gariepy J, Levenson J, Rendu F, Simon A. Decreased number of circulating CD34+KDR+ cells in asymptomatic subjects with preclinical atherosclerosis. Atherosclerosis. 2007 Mar;191(1):115-20. doi: 10.1016/j.atherosclerosis.2006.02.041. Epub 2006 Apr 18.

Divoux A, Sandor K, Bojcsuk D, Talukder A, Li X, Balint BL, Osborne TF, Smith SR. Differential open chromatin profile and transcriptomic signature define depot-specific human subcutaneous preadipocytes: primary outcomes. Clin Epigenetics. 2018 Nov 26;10(1):148. doi: 10.1186/s13148-018-0582-0.

Divoux A, Xie H, Li JL, Karastergiou K, Perera RJ, Chang RJ, Fried SK, Smith SR. MicroRNA-196 Regulates HOX Gene Expression in Human Gluteal Adipose Tissue. Obesity (Silver Spring). 2017 Aug;25(8):1375-1383. doi: 10.1002/oby.21896. Epub 2017 Jun 25.

Related Links

Other Identifiers

348525

TRIMDFH 348525

More Related Trials