Polycystic Ovary SyndromeNCT02506946
NAFLD in Adolescents and Young Adults With PCOS
An observational study of Polycystic Ovary Syndrome and Non-Alcoholic Fatty Liver Disease, run by Columbia University at 1 site in United States.
Trial summary
This project focuses on an at-risk adolescent and young adult population who may gain long-term health benefits from detection of risk factors at a young age. The primary aims of this proposal are: 1) To observe whether adolescents and young adults with Polycystic Ovary Syndrome (PCOS) are more likely to have elevated… Read more about this study
- Who is it for?
- Ages 14 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Non-Alcoholic Fatty Liver Disease, Metabolic Syndrome
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jun 2027
- Phase
- Observational
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 14 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy adolescent girls and young women 14 - 25 years with and without PCOS
Who may be able to join
- All: Healthy; between 14 and 25 years; at least 2 years postmenarche
- PCOS: Clinical hyperandrogenism and/or hyperandrogenemia, menstrual dysfunction (oligomenorrhea or amenorrhea) and exclusion of other known disorders. PCOS will be diagnosed using the NIH 1990 criteria.
- Controls: Regular menses; no clinical hyperandrogenism and/or hyperandrogenemia
Who cannot join
- Past or present history of a medical disorder or medication known to affect body composition, insulin secretion and sensitivity, or the growth hormone (GH)-insulin-like growth factor 1 (IGF1) axis (eg steroid hormone or thyroid replacement).
- History of current or past pregnancy
- Hormonal contraceptive or metformin use within 3 months of enrollment
- Nonclassical congenital adrenal hyperplasia
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Nonalcoholic Fatty Liver Disease (NAFLD), Insulin Resistance and Dyslipidemia in Adolescents and Young Adults With Polycystic Ovary Syndrome (PCOS)
This project focuses on an at-risk adolescent and young adult population who may gain long-term health benefits from detection of risk factors at a young age. The primary aims of this proposal are: 1) To observe whether adolescents and young adults with Polycystic Ovary Syndrome (PCOS) are more likely to have elevated liver fat (>/=4.8%) than controls by studying liver fat deposition measured by magnetic resonance spectroscopy (MRS); 2) To assess the association of percentage liver fat with biomarkers of Non-alcoholic fatty liver disease (NAFLD), dyslipidemia, insulin resistance and body composition in PCOS and controls.
In the proposed study, 40 adolescents and young adults with PCOS and 40 age-comparable control subjects will be evaluated for metabolic disturbances and elevated liver fat using noninvasive and state-of-the-art techniques including MRI, dual-energy x-ray absorptiometry and an oral glucose tolerance test in order to fully assess the metabolic and body composition differences between these groups. This research proposal represents a critical step in understanding the metabolic and cardiovascular comorbidities of PCOS and their relationship to NAFLD. The investigator hopes to use the results generated by this research proposal in order to lay the groundwork for the prevention and treatment of metabolic disorders in adolescents with PCOS. The overarching goal is to decrease and prevent lifelong morbidity associated with this common disorder.
Read the detailed description
PCOS is a common condition that frequently presents in adolescence and young adulthood and is defined by the presence of hyperandrogenism and ovulatory dysfunction. Affected individuals are at increased risk of insulin resistance, NAFLD and dyslipidemia, which are features associated with the metabolic syndrome, a major public health concern. The associations between PCOS and both insulin resistance and dyslipidemia have been extensively described; however, its association with NAFLD has only recently been noted and superficially studied in adolescents and young adults. Additionally, it has not yet been fully elucidated why seemingly healthy nonobese adolescents with PCOS are predisposed to insulin resistance and its related complications. The susceptibility of certain PCOS patients to developing NAFLD is theorized to be due to the following potentiating factors: insulin resistance, hyperandrogenemia, and a genetic predisposition.
- Keywords
- Polycystic Ovary Syndrome, Non-Alcoholic Fatty Liver Disease, Adolescents, Young Women, MRI, MRS, DXA, Hirsutism, Amenorrhea, Metabolic syndrome, Dyslipidemia, Percentage liver fat
- Medical subject headings
- Polycystic Ovary Syndrome, Non-alcoholic Fatty Liver Disease, Metabolic Syndrome, Hirsutism, Amenorrhea, Dyslipidemias
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 subjects | Forty adolescents and young adults between the ages of 14 and 25 years with Polycystic Ovary Syndrome (PCOS) at least two years past menarche. | |
| Control subjects | Forty unaffected adolescents and young adults between the ages of 14 and 25 years at least two years past menarche. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in percentage liver fat between PCOS and controls in adolescents and young adults
To compare percentage liver fat by magnetic resonance spectroscopy between adolescents and young adults with PCOS and controls to determine if there is a difference between these groups.
Measured: 1 day
Secondary outcomes (4)
The association of percentage liver fat by magnetic resonance spectroscopy with insulin resistance as measured by HOMA-IR.
The association of percent liver fat with insulin resistance as measured by HOMA-IR will be measured by correlation/regression.
Measured: 1 day
The association of percentage liver fat by magnetic resonance spectroscopy with triglycerides
The association of percent liver fat with triglycerides will be measured by correlation/regression.
Measured: 1 day
The association of percentage liver fat by magnetic resonance spectroscopy with visceral adipose tissue (VAT)
The association of percent liver fat with visceral adipose tissue (VAT) will be measured by correlation/regression.
Measured: 1 day
The association of percentage liver fat by magnetic resonance spectroscopy with total body adipose tissue
The association of percent liver fat with total body adipose tissue will be measured by correlation/regression.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startJul 2013
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aviva Sopher, MD, MS, MS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506946
- Sponsor's protocol ID
- AAAA7793
- Status last verified
- Sep 2026
- First submitted
- 21 Jul 2015
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will consider this
Publications
Sopher AB, Grigoriev G, Laura D, Cameo T, Lerner JP, Chang RJ, McMahon DJ, Oberfield SE. Anti-Mullerian hormone may be a useful adjunct in the diagnosis of polycystic ovary syndrome in nonobese adolescents. J Pediatr Endocrinol Metab. 2014 Nov;27(11-12):1175-9. doi: 10.1515/jpem-2014-0128.
PubMed 25003376Sopher AB, Gerken AT, Blaner WS, Root JM, McMahon DJ, Oberfield SE. Metabolic manifestations of polycystic ovary syndrome in nonobese adolescents: retinol-binding protein 4 and ectopic fat deposition. Fertil Steril. 2012 Apr;97(4):1009-15. doi: 10.1016/j.fertnstert.2012.01.111. Epub 2012 Feb 17.
PubMed 22341881