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Trial record 1 of 2 for:    Understanding the Risk of Comorbidities in Girls with Polycystic Ovary Syndrome
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NAFLD in Adolescents and Young Adults With PCOS

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ClinicalTrials.gov Identifier: NCT02506946
Recruitment Status : Active, not recruiting
First Posted : July 23, 2015
Last Update Posted : July 20, 2022
Sponsor:
Information provided by (Responsible Party):
Aviva B. Sopher, Columbia University

Study Description
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Brief 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 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.


Condition or disease
Polycystic Ovary Syndrome Non-Alcoholic Fatty Liver Disease Metabolic Syndrome

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Nonalcoholic Fatty Liver Disease (NAFLD), Insulin Resistance and Dyslipidemia in Adolescents and Young Adults With Polycystic Ovary Syndrome (PCOS)
Study Start Date : July 2013
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Difference in percentage liver fat between PCOS and controls in adolescents and young adults [ Time Frame: 1 day ]
    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.


Secondary Outcome Measures :
  1. The association of percentage liver fat by magnetic resonance spectroscopy with insulin resistance as measured by HOMA-IR. [ Time Frame: 1 day ]
    The association of percent liver fat with insulin resistance as measured by HOMA-IR will be measured by correlation/regression.

  2. The association of percentage liver fat by magnetic resonance spectroscopy with triglycerides [ Time Frame: 1 day ]
    The association of percent liver fat with triglycerides will be measured by correlation/regression.

  3. The association of percentage liver fat by magnetic resonance spectroscopy with visceral adipose tissue (VAT) [ Time Frame: 1 day ]
    The association of percent liver fat with visceral adipose tissue (VAT) will be measured by correlation/regression.

  4. The association of percentage liver fat by magnetic resonance spectroscopy with total body adipose tissue [ Time Frame: 1 day ]
    The association of percent liver fat with total body adipose tissue will be measured by correlation/regression.


Biospecimen Retention:   Samples Without DNA
Blood samples will be stored in a freezer for assays requiring batch testing

Eligibility Criteria
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Ages Eligible for Study:   14 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy adolescent girls and young women 14 - 25 years with and without PCOS
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02506946


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Aviva Sopher, MD, MS, MS Columbia University
More Information
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Additional Information:

Publications:

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Responsible Party: Aviva B. Sopher, Assistant Professor of Pediatrics, Columbia University
ClinicalTrials.gov Identifier: NCT02506946    
Other Study ID Numbers: AAAA7793
First Posted: July 23, 2015    Key Record Dates
Last Update Posted: July 20, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We will consider this
Keywords provided by Aviva B. Sopher, Columbia University:
Polycystic Ovary Syndrome
Young Women
Metabolic syndrome
Non-Alcoholic Fatty Liver Disease
Adolescents
MRI
 MRS
DXA
Hirsutism
Amenorrhea
Dyslipidemia
Percentage liver fat
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Metabolic Syndrome
Syndrome
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Disease
Pathologic Processes
Digestive System Diseases
Insulin Resistance
 Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Urogenital Diseases
Genital Diseases
Gonadal Disorders
Endocrine System Diseases