NAFLD in Adolescents and Young Adults With PCOS

Recruiting

• Conditions: Non-Alcoholic Fatty Liver Disease; Metabolic Syndrome; Polycystic Ovary Syndrome

• Registration Number: NCT02506946
• Lead Sponsor: Columbia University

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.

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 Timeline

• Study Start: 2013-07
• Study First Submitted: 2015-07-21
• Study First Submitted QC: 2015-07-21
• Study First Posted: 2015-07-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in percentage liver fat between PCOS and controls in adolescents and young adults	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

Name	Time	Method
The association of percentage liver fat by magnetic resonance spectroscopy with insulin resistance as measured by HOMA-IR.	1 day	The association of percent liver fat with insulin resistance as measured by HOMA-IR will be measured by correlation/regression.
The association of percentage liver fat by magnetic resonance spectroscopy with triglycerides	1 day	The association of percent liver fat with triglycerides will be measured by correlation/regression.
The association of percentage liver fat by magnetic resonance spectroscopy with visceral adipose tissue (VAT)	1 day	The association of percent liver fat with visceral adipose tissue (VAT) will be measured by correlation/regression.
The association of percentage liver fat by magnetic resonance spectroscopy with total body adipose tissue	1 day	The association of percent liver fat with total body adipose tissue will be measured by correlation/regression.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States