PCOSEPICNCT04034706
Transcriptional and Epigenetic Program of PCOS Women
An observational study of PCOS, run by AdventHealth Translational Research Institute at 1 site in United States.
Trial summary
The main goal is to reveal differences in global gene expression in two different adipose tissue (AT) depots of females with and without polycystic ovary syndrome (PCOS) and how these are influenced by upstream epigenetic markers Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PCOS
- What is being tested?
- DEXA, Magnetic Resonance (MR) Assessment of the Abdomen and MR assessment of Whole Body Fat
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2020to 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Recruitment methods utilized may include, but will not be limited to, the following: recruitment from within the AdventHealth Translational Research Institute's patient population: electronic medical records and database searches (including third party recruitment vendors); advertising in multiple media such as print ads, flyers, brochures, posters; radio ads; television spots; and internet/social media advertising.
Who may be able to join
- Women;
- Age 18-45 years inclusive;
- BMI 23-40 kg/m2 inclusive;
- HbA1C ≤ 6.0% or fasting plasma glucose < 126 mg/dL;
- Weight stable (± 3 kg) during the 3 months prior to enrollment;
- Women must be > 9 months post-partum;
Show all 9Show fewer
- For PCOS: A documented history of PCOS from their physician according to the Androgen Excess (AE)-PCOS criteria: (defined by the presence of hyperandrogenism (clinical and/or biochemical), ovarian dysfunction (oligo-anovulation and/or polycystic ovaries), and the exclusion of related disorders (eg. hypoadrenalism, ovarian tumors)
- Regular menstrual cycle for females without PCOS
- Able to provide written, informed consent.
Who cannot join
- Postmenopausal women
- Women with hysterectomy
- Pregnancy, lactation or < 9 months postpartum from the scheduled date of screening.
- Fasting plasma glucose > 126 mg/dL, or HbA1c > 6% or diagnosis with Type 2 Diabetes (T2D) or Type 1 Diabetes (T1D)
- History or presence of cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months, clinically significant abnormalities on EKG), presence of cardiac pacemaker, implanted cardiac defibrillator.
- Liver disease (AST or ALT >2.5 times the upper limit of normal)
Show all 31Show fewer
- Kidney disease (creatinine >1.6 mg/dl or estimated GFR <60 ml/min)
- Dyslipidemia, including triglycerides >500 mg/dl, LDL >200 mg/dl
- Anemia (hemoglobin <11 g/dl)
- Thyroid dysfunction (suppressed thyroid-stimulating hormone, elevated TSH <10 µIU/ml if symptomatic or elevated TSH >10 µIU/ml if asymptomatic)
- Uncontrolled hypertension (BP >160 mmHg systolic or >100 mmHg diastolic)
- Elevated hsCRP or known active infection
- History of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable)
- History of drug or alcohol abuse (> 3 drinks per day) within the last 5 years. Current drug use may be determined by plasma or urine drug screens.
- psychiatric disease prohibiting adherence to study protocol.
- History of organ transplant.
- Known history of HIV, active Hepatitis A, B or C or tuberculosis.
- History of bariatric surgery.
- Current smokers (smoking within the past 3 months).
- Current use of beta-adrenergic blocking agents.
- Use of oral or injectable anti-hyperglycemic agents: metformin, sulfonylureas, DPP IV inhibitors, SGLT-2 inhibitors, thiazolidinediones, acarbose, GLP-1 analogs and insulin unless willing to undertake a washout period of 15 days for metformin and GLP-1 analogs and undergo subsequent laboratory screening tests.
- Gonadotropin Releasing Hormone (GnRH) and/or Antiandrogen use within the last 2 months.
- Use of any medications known to influence fat and/or energy metabolism (eg growth hormone therapy, glucocorticoids [steroids], etc.)
- Initiation or change in hormone replacement therapy within the past 3 months (including, but not limited to thyroid hormone, estrogen replacement therapy or In Vitro Fertilization therapy).
- Current treatment with blood thinners or antiplatelet medications that cannot be safely stopped for biopsy and testing procedures.
- Not able or willing to have DXA scans or are above the acceptable weight limit (450 lbs) of the DXA scanner.
- Presence of any condition that, in the opinion of the Investigators, compromises participant safety or data integrity or the participant's ability to complete study visits.
- Not able to participate in MRI assessments due to:
- Metal implants (pacemaker, non-removable body piercings, aneurysm clips) based on Investigator's judgment at screening
- Physical limitations or equipment tolerances (e.g., MRI bore size) based on Investigator's judgment at screening
- Inability to tolerate MRI imaging without sedation or claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site
AdventHealth Translational Research Institute
Orlando, Florida, 32804
About this study
The main goal is to reveal differences in global gene expression in two different adipose tissue (AT) depots of females with and without polycystic ovary syndrome (PCOS) and how these are influenced by upstream epigenetic markers
- Conditions
- PCOS
- Being tested
- DEXA, Magnetic Resonance (MR) Assessment of the Abdomen, MR assessment of Whole Body Fat, Adipose tissue biopsy, Oral glucose tolerance test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEXAOther
DEXA Scans will be performed to measure body fat and estimate muscle mass using a General Electric Lunar iDXA whole-body scanner.
Magnetic Resonance (MR) Assessment of the AbdomenOther
Include measures to assess liver lipid content and stiffness and perform volumetric fat quantitation.
MR assessment of Whole Body FatOther
Volumetric measurement of fat, muscle and bone
Adipose tissue biopsyProcedure or surgery
0.5 cm incision of the upper-outer right vastus lateralis, and either a 3-4mm Mercedes Liposuction needle, or a 4-6 mm Bergstrom needle will be inserted to aspirate approximately 7 grams of adipose tissue.
Oral glucose tolerance testOther
Glucose tolerance will be assessed with a 75 g oral glucose tolerance test (OGTT). Subjects will be studied after an overnight fast.
| Study group | Role | What they receive |
|---|---|---|
| PCOS females | Females diagnosed with PCOS with a BMI between 23 and 40 kg/m2. Receives: Other: DEXA; Other: Magnetic Resonance (MR) Assessment of the Abdomen; Other: MR assessment of Whole Body Fat; Procedure: Adipose tissue biopsy; Other: Oral glucose tolerance test | |
| Non-PCOS control females | Females without PCOS with a BMI between 23 and 40 kg/m2 split into 2 groups- apple shaped and pear shaped. Receives: Other: DEXA; Other: Magnetic Resonance (MR) Assessment of the Abdomen; Other: MR assessment of Whole Body Fat; Procedure: Adipose tissue biopsy; Other: Oral glucose tolerance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epigenomic and transcriptomic differences in abdominal vs gluteal subcutaneous adipose tissue between females with and without polycystic ovary syndrome
Epigenetic profiles (DNA methylation) and gene expression (RNA-seq) will be performed on whole tissue abdominal fat and gluteofemoral fat biopsies in addition to cultured pre-adipocytes and adipocytes.
Measured: 6 months after the last participant will be enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start31 Jan 2020
- Primary completion12 Apr 2023
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for PCOSStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Smith, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034706
- Sponsor's protocol ID
- 1354588
- Acronym
- EPIC
- Status last verified
- Mar 2025
- First submitted
- 24 Jul 2019
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abbott DH, Barnett DK, Bruns CM, Dumesic DA. Androgen excess fetal programming of female reproduction: a developmental aetiology for polycystic ovary syndrome? Hum Reprod Update. 2005 Jul-Aug;11(4):357-74. doi: 10.1093/humupd/dmi013.
PubMed 15941725Abbott DH, Dumesic DA, Eisner JR, Colman RJ, Kemnitz JW. Insights into the development of polycystic ovary syndrome (PCOS) from studies of prenatally androgenized female rhesus monkeys. Trends Endocrinol Metab. 1998 Feb;9(2):62-7. doi: 10.1016/s1043-2760(98)00019-8.
PubMed 18406243Azziz R, Carmina E, Chen Z, Dunaif A, Laven JS, Legro RS, Lizneva D, Natterson-Horowtiz B, Teede HJ, Yildiz BO. Polycystic ovary syndrome. Nat Rev Dis Primers. 2016 Aug 11;2:16057. doi: 10.1038/nrdp.2016.57.
PubMed 27510637Barber TM, Golding SJ, Alvey C, Wass JA, Karpe F, Franks S, McCarthy MI. Global adiposity rather than abnormal regional fat distribution characterizes women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2008 Mar;93(3):999-1004. doi: 10.1210/jc.2007-2117. Epub 2007 Dec 18.
PubMed 18089693Bjorntorp P. Adipose tissue distribution and function. Int J Obes. 1991 Sep;15 Suppl 2:67-81.
PubMed 1794941Bos G, Snijder MB, Nijpels G, Dekker JM, Stehouwer CD, Bouter LM, Heine RJ, Jansen H. Opposite contributions of trunk and leg fat mass with plasma lipase activities: the Hoorn study. Obes Res. 2005 Oct;13(10):1817-23. doi: 10.1038/oby.2005.221.
PubMed 16286530Ciaraldi TP, Aroda V, Mudaliar S, Chang RJ, Henry RR. Polycystic ovary syndrome is associated with tissue-specific differences in insulin resistance. J Clin Endocrinol Metab. 2009 Jan;94(1):157-63. doi: 10.1210/jc.2008-1492. Epub 2008 Oct 14.
PubMed 18854391de Koning L, Merchant AT, Pogue J, Anand SS. Waist circumference and waist-to-hip ratio as predictors of cardiovascular events: meta-regression analysis of prospective studies. Eur Heart J. 2007 Apr;28(7):850-6. doi: 10.1093/eurheartj/ehm026. Epub 2007 Apr 2.
PubMed 17403720Diamanti-Kandarakis E, Dunaif A. Insulin resistance and the polycystic ovary syndrome revisited: an update on mechanisms and implications. Endocr Rev. 2012 Dec;33(6):981-1030. doi: 10.1210/er.2011-1034. Epub 2012 Oct 12.
PubMed 23065822Divoux A, Karastergiou K, Xie H, Guo W, Perera RJ, Fried SK, Smith SR. Identification of a novel lncRNA in gluteal adipose tissue and evidence for its positive effect on preadipocyte differentiation. Obesity (Silver Spring). 2014 Aug;22(8):1781-5. doi: 10.1002/oby.20793. Epub 2014 May 23.
PubMed 24862299Elbers 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 9950792Elbers 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 9215270Frayn KN. Adipose tissue as a buffer for daily lipid flux. Diabetologia. 2002 Sep;45(9):1201-10. doi: 10.1007/s00125-002-0873-y. Epub 2002 Jul 24.
PubMed 12242452Guo Z, Johnson CM, Jensen MD. Regional lipolytic responses to isoproterenol in women. Am J Physiol. 1997 Jul;273(1 Pt 1):E108-12. doi: 10.1152/ajpendo.1997.273.1.E108.
PubMed 9252486Horowitz JF, Klein S. Whole body and abdominal lipolytic sensitivity to epinephrine is suppressed in upper body obese women. Am J Physiol Endocrinol Metab. 2000 Jun;278(6):E1144-52. doi: 10.1152/ajpendo.2000.278.6.E1144.
PubMed 10827018
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcriptional and Epigenetic Program of PCOS Women
- ClinicalTrials.gov ID
- NCT04034706
- Acronym / sponsor ID
- EPIC / 1354588
- Conditions
- PCOS
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (actual)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Jul 2019 (actual)
- 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 main goal is to reveal differences in global gene expression in two different adipose tissue (AT) depots of females with and without polycystic ovary syndrome (PCOS) and how these are influenced by upstream epigenetic markers
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS females | – | Other: DEXA, Other: Magnetic Resonance (MR) Assessment of the Abdomen, Other: MR assessment of Whole Body Fat, Procedure: Adipose tissue biopsy, Other: Oral glucose tolerance testFemales diagnosed with PCOS with a BMI between 23 and 40 kg/m2. |
| Non-PCOS control females | – | Other: DEXA, Other: Magnetic Resonance (MR) Assessment of the Abdomen, Other: MR assessment of Whole Body Fat, Procedure: Adipose tissue biopsy, Other: Oral glucose tolerance testFemales without PCOS with a BMI between 23 and 40 kg/m2 split into 2 groups- apple shaped and pear shaped. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Recruitment methods utilized may include, but will not be limited to, the following: recruitment from within the AdventHealth Translational Research Institute's patient population: electronic medical records and database searches (including third party recruitment vendors); advertising in multiple media such as print ads, flyers, brochures, posters; radio ads; television spots; and internet/social media advertising.
Key inclusion criteria (9 listed)
- Women;
- Age 18-45 years inclusive;
- BMI 23-40 kg/m2 inclusive;
- HbA1C ≤ 6.0% or fasting plasma glucose < 126 mg/dL;
- Weight stable (± 3 kg) during the 3 months prior to enrollment;
Key exclusion criteria (31 listed)
- Postmenopausal women
- Women with hysterectomy
- Pregnancy, lactation or < 9 months postpartum from the scheduled date of screening.
- Fasting plasma glucose > 126 mg/dL, or HbA1c > 6% or diagnosis with Type 2 Diabetes (T2D) or Type 1 Diabetes (T1D)
- History or presence of cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months, clinically significant abnormalities on EKG), presence of cardiac pacemaker, implanted cardiac defibrillator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEXADEXA Scans will be performed to measure body fat and estimate muscle mass using a General Electric Lunar iDXA whole-body scanner. | Other | Non-PCOS control females, PCOS females |
| Magnetic Resonance (MR) Assessment of the AbdomenInclude measures to assess liver lipid content and stiffness and perform volumetric fat quantitation. | Other | Non-PCOS control females, PCOS females |
| MR assessment of Whole Body FatVolumetric measurement of fat, muscle and bone | Other | Non-PCOS control females, PCOS females |
| Adipose tissue biopsy0.5 cm incision of the upper-outer right vastus lateralis, and either a 3-4mm Mercedes Liposuction needle, or a 4-6 mm Bergstrom needle will be inserted to aspirate approximately 7 grams of adipose tissue. | Procedure or surgery | Non-PCOS control females, PCOS females |
| Oral glucose tolerance testGlucose tolerance will be assessed with a 75 g oral glucose tolerance test (OGTT). Subjects will be studied after an overnight fast. | Other | Non-PCOS control females, PCOS females |
Primary outcome
Epigenomic and transcriptomic differences in abdominal vs gluteal subcutaneous adipose tissue between females with and without polycystic ovary syndrome
Time frame: 6 months after the last participant will be enrolled
Epigenetic profiles (DNA methylation) and gene expression (RNA-seq) will be performed on whole tissue abdominal fat and gluteofemoral fat biopsies in addition to cultured pre-adipocytes and adipocytes.
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 13 Mar 2025.
- Background: PubMed 15941725Abbott DH, Barnett DK, Bruns CM, Dumesic DA. Androgen excess fetal programming of female reproduction: a developmental aetiology for polycystic ovary syndrome? Hum Reprod Update. 2005 Jul-Aug;11(4):357-74. doi: 10.1093/humupd/dmi013.
- Background: PubMed 18406243Abbott DH, Dumesic DA, Eisner JR, Colman RJ, Kemnitz JW. Insights into the development of polycystic ovary syndrome (PCOS) from studies of prenatally androgenized female rhesus monkeys. Trends Endocrinol Metab. 1998 Feb;9(2):62-7. doi: 10.1016/s1043-2760(98)00019-8.
- Background: PubMed 27510637Azziz R, Carmina E, Chen Z, Dunaif A, Laven JS, Legro RS, Lizneva D, Natterson-Horowtiz B, Teede HJ, Yildiz BO. Polycystic ovary syndrome. Nat Rev Dis Primers. 2016 Aug 11;2:16057. doi: 10.1038/nrdp.2016.57.
- Background: PubMed 18089693Barber TM, Golding SJ, Alvey C, Wass JA, Karpe F, Franks S, McCarthy MI. Global adiposity rather than abnormal regional fat distribution characterizes women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2008 Mar;93(3):999-1004. doi: 10.1210/jc.2007-2117. Epub 2007 Dec 18.
- Background: PubMed 1794941Bjorntorp P. Adipose tissue distribution and function. Int J Obes. 1991 Sep;15 Suppl 2:67-81.
- Background: PubMed 16286530Bos G, Snijder MB, Nijpels G, Dekker JM, Stehouwer CD, Bouter LM, Heine RJ, Jansen H. Opposite contributions of trunk and leg fat mass with plasma lipase activities: the Hoorn study. Obes Res. 2005 Oct;13(10):1817-23. doi: 10.1038/oby.2005.221.
- Background: PubMed 18854391Ciaraldi TP, Aroda V, Mudaliar S, Chang RJ, Henry RR. Polycystic ovary syndrome is associated with tissue-specific differences in insulin resistance. J Clin Endocrinol Metab. 2009 Jan;94(1):157-63. doi: 10.1210/jc.2008-1492. Epub 2008 Oct 14.
- Background: PubMed 17403720de Koning L, Merchant AT, Pogue J, Anand SS. Waist circumference and waist-to-hip ratio as predictors of cardiovascular events: meta-regression analysis of prospective studies. Eur Heart J. 2007 Apr;28(7):850-6. doi: 10.1093/eurheartj/ehm026. Epub 2007 Apr 2.
- Background: PubMed 23065822Diamanti-Kandarakis E, Dunaif A. Insulin resistance and the polycystic ovary syndrome revisited: an update on mechanisms and implications. Endocr Rev. 2012 Dec;33(6):981-1030. doi: 10.1210/er.2011-1034. Epub 2012 Oct 12.
- Background: PubMed 24862299Divoux A, Karastergiou K, Xie H, Guo W, Perera RJ, Fried SK, Smith SR. Identification of a novel lncRNA in gluteal adipose tissue and evidence for its positive effect on preadipocyte differentiation. Obesity (Silver Spring). 2014 Aug;22(8):1781-5. doi: 10.1002/oby.20793. Epub 2014 May 23.
- 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 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.
- Website for AdventHealth Translational Research InstituteLink provided by the sponsor.
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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.
Steven Smith, MD principal investigator
Principal Investigator
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 PCOS, 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 9 inclusion and 31 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 13 Mar 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?
Epigenomic and transcriptomic differences in abdominal vs gluteal subcutaneous adipose tissue between females with and without polycystic ovary syndrome (time frame: 6 months after the last participant will be enrolled). 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 NCT04034706, which also lists 23 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 13 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.