THE ASSOCIATION BETWEEN FATTY LIVER (NAFLD) DISEASE AND PCOS

November 27, 2012 updated by: Assy Nimer

Since both pathologies (PCOS and NAFLD) involve disturbed carbohydrate economy, which revolve around insulin resistance, it is tempting to examine the specific "liver profile" of women with PCOD. Furthermore, it would be of great importance if lean women who suffer from PCOD would be revealed to shere cardiovascular risks with their more overweight peers.

Patients - women who will be diagnosed with PCOD following their initial referal to our fertility clinic. Controls - normal ovulatory women who approached our fertility clinic due to either unexplained or male factor infertility.

Workup - history for menstrual pattern; Clinical evaluation for features of hyperandrogenism; ultrasonographic documentation of ovarian morphology; follicular phase hormonal profile for validation of the diagnosis and for ruling out other pathologies which may cause anovulation.

Liver profiling - The following blood tests will be used for the biochemical profiling: fasting glucose and insulin, CRP, HDL-cholesterol, triglycerides, AST, ALT, GGT, LDH, alkaline phosphatase, total bilirubin, direct bilirubin, ferritin, HBA1C and micro albumin ratio.

FibroScan® will be used to measure liver stiffness.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Safed, Israel, 13100
        • Liver Clinic, ZIv Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients - women who will be diagnosed with PCOD following their initial referal to our fertility clinic. Controls - normal ovulatory women who approached our fertility clinic due to either unexplained or male factor infertility.

Description

Workup - history for menstrual pattern; Clinical evaluation for features of hyperandrogenism; ultrasonographic documentation of ovarian morphology; follicular phase hormonal profile for validation of the diagnosis and for ruling out other pathologies which may cause anovulation.

Liver profiling - The following blood tests will be used for the biochemical profiling: fasting glucose and insulin, CRP, HDL-cholesterol, triglycerides, AST, ALT, GGT, LDH, alkaline phosphatase, total bilirubin, direct bilirubin, ferritin, HBA1C and micro albumin ratio.

FibroScan® will be used to measure liver stiffness, as previously described

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assy Nimer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Study Registration Dates

First Submitted

November 25, 2012

First Submitted That Met QC Criteria

November 27, 2012

First Posted (Estimate)

November 28, 2012

Study Record Updates

Last Update Posted (Estimate)

November 28, 2012

Last Update Submitted That Met QC Criteria

November 27, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0068-12-ZIV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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