NAFLD in Adolescents and Young Adults With PCOS

NCT02506946 | Suspended

• 1 other identifier: AAAA7793
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Polycystic Ovary Syndrome; Non-Alcoholic Fatty Liver Disease

Keywords

Polycystic Ovary Syndrome; Non-Alcoholic Fatty Liver Disease; Adolescents; Young Women; MRI; MRS; DXA; Hirsutism; Amenorrhea; Metabolic syndrome; Dyslipidemia; Percentage liver fat

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Secondary Outcomes (4)

• The association of percentage liver fat by magnetic resonance spectroscopy with insulin resistance as measured by HOMA-IR.

  1 day

• The association of percentage liver fat by magnetic resonance spectroscopy with triglycerides

  1 day

• The association of percentage liver fat by magnetic resonance spectroscopy with visceral adipose tissue (VAT)

  1 day

• The association of percentage liver fat by magnetic resonance spectroscopy with total body adipose tissue

  1 day

Study Arms (2)

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.

Eligibility Criteria

• Age: 14 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adolescent girls and young women 14 - 25 years with and without PCOS

You may qualify if:

• All: Healthy; between 14 and 25 years; at least 2 years postmenarche
• Controls: Regular menses; no clinical hyperandrogenism and/or hyperandrogenemia

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (2)

• 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.

  PMID: 25003376 BACKGROUND

• Sopher 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.

  PMID: 22341881 BACKGROUND

Related Links

• Information about PCOS
• Information about NAFLD

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be stored in a freezer for assays requiring batch testing

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Non-alcoholic Fatty Liver Disease; Metabolic Syndrome; Hirsutism; Amenorrhea; Dyslipidemias

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Virilism; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Pathologic Processes; Lipid Metabolism Disorders

Study Officials

• Aviva Sopher, MD, MS, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: July 23, 2015
• Study Start: July 1, 2013
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: July 2, 2026

Record last verified: 2026-07

Locations

US (1)