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Trial record 46 of 345 for:    hepatic steatosis AND fat AND Nonalcoholic Fatty Liver

NAFLD in Adolescents and Young Adults With PCOS

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ClinicalTrials.gov Identifier: NCT02506946
Recruitment Status : Recruiting
First Posted : July 23, 2015
Last Update Posted : November 4, 2016
Sponsor:
Information provided by (Responsible Party):
Aviva B. Sopher, 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.


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.

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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 : July 2019
Estimated Study Completion Date : July 2020


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.



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


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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

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


Contacts
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Contact: Hailey Roumimper, AB 212-305-1518 hr2388@cumc.columbia.edu
Contact: Aviva B Sopher, MD, MS, MS 212-305-6559 ahs32@cumc.columbia.edu

Locations
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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Hailey Roumimper, AB    212-305-1518    hr2388@cumc.columbia.edu   
Contact: Aviva B Sopher, MD, MS, MS    212-305-9362    ahs32@cumc.columbia.edu   
Principal Investigator: Aviva B Sopher, MD, MS, MS         
Sub-Investigator: Sharon E Oberfield, MD         
Sub-Investigator: Ilene Fennoy, MD, MPH         
Sub-Investigator: Abeer Hassoun, MD         
Sub-Investigator: Jodi Lerner, MD         
Sub-Investigator: Camila Pereira-Eshargi, MD         
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Aviva Sopher, MD, MS, MS Columbia University

Additional Information:
Publications:
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Responsible Party: Aviva B. Sopher, Assistant Professor of Pediatrics, Columbia University
ClinicalTrials.gov Identifier: NCT02506946     History of Changes
Other Study ID Numbers: AAAA7793
First Posted: July 23, 2015    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016
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:
Non-Alcoholic Fatty Liver Disease
Percentage liver fat
Polycystic Ovary Syndrome
Adolescents
Young Women
MRI
MRS
DXA
Hirsutism
Amenorrhea
Metabolic syndrome
Dyslipidemia

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Syndrome
Metabolic Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Digestive System Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases