Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2024-01-22
2028-12-31
Brief Summary
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Young women with a condition called polycystic ovary syndrome (PCOS) have a high risk for NAFLD, and they often have high androgen levels too. So the researchers are recruiting young women with PCOS as well as those without PCOS, and will compare changes in NAFLD over time between young women with and without PCOS.
This study is funded by the National Institutes of Health
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Detailed Description
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As existing data support androgenic effects on hepatic and visceral fat in women, the researchers will now determine the relationship of androgens with liver injury and progression in PCOS and the potential mechanistic contributions of VAT and aberrant lipid metabolism to this process. The team includes clinical and translational researchers at two centers (UCSF and Duke) with expertise in NAFLD, PCOS, obesity, and lipid metabolism, with a track record of collaboration. The study team will leverage an existing well-characterized PCOS cohort29 to follow 150 reproductive-aged women with NASH (125 PCOS and 25 non-PCOS controls) to accomplish this.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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MASLD and PCOS hyperandrogenism
Patients with MASLD and PCOS with the phenotype of hyperandrogenism
No interventions assigned to this group
MASLD and PCOS non-hyperandrogenism
Patients with MASLD and PCOS with the phenotype of non-hyperandrogenism
No interventions assigned to this group
MASLD and no-PCOS
Patients with metabolic dysfunction-associated steatotic liver disease (MASLD) and no PCOS
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* PCOS
* Non-PCOS
Exclusion Criteria
* Current pregnancy
* Other causes of hepatic steatosis
* Weight loss of more than 10% body weight in the last 6 months
18 Years
42 Years
FEMALE
No
Sponsors
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Duke University
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Monika A Sarkar, M.D., M.A.S
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Ayako Suzuki, M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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University of California San Francisco
San Francisco, California, United States
Duke University
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Sarkar M, Terrault N, Chan W, Cedars MI, Huddleston HG, Duwaerts CC, Balitzer D, Gill RM. Polycystic ovary syndrome (PCOS) is associated with NASH severity and advanced fibrosis. Liver Int. 2020 Feb;40(2):355-359. doi: 10.1111/liv.14279. Epub 2019 Nov 12.
Sarkar MA, Suzuki A, Abdelmalek MF, Yates KP, Wilson LA, Bass NM, Gill R, Cedars M, Terrault N; NASH Clinical Research Network. Testosterone is Associated With Nonalcoholic Steatohepatitis and Fibrosis in Premenopausal Women With NAFLD. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1267-1274.e1. doi: 10.1016/j.cgh.2020.09.045. Epub 2020 Oct 1.
Sarkar M, Yates K, Suzuki A, Lavine J, Gill R, Ziegler T, Terrault N, Dhindsa S. Low Testosterone Is Associated With Nonalcoholic Steatohepatitis and Fibrosis Severity in Men. Clin Gastroenterol Hepatol. 2021 Feb;19(2):400-402.e2. doi: 10.1016/j.cgh.2019.11.053. Epub 2019 Dec 5.
Sarkar M, Terrault N, Duwaerts CC, Tien P, Cedars MI, Huddleston H. The Association of Hispanic Ethnicity with Nonalcoholic Fatty Liver Disease in Polycystic Ovary Syndrome. Curr Opin Gynecol Obstet. 2018 Feb 20;1(1):24-33. Epub 2018 Apr 5.
Other Identifiers
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23-39040
Identifier Type: -
Identifier Source: org_study_id
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