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THE ASSOCIATION BETWEEN FATTY LIVER (NAFLD) DISEASE AND PCOS

Sponsor
Assy Nimer (Other)
Overall Status
Unknown status
CT.gov ID
NCT01735799
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Time Perspective:
    Prospective
    Study Start Date :
    Nov 1, 2012

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 50 Years
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      No

      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Liver Clinic, ZIv Medical Center Safed Israel 13100

      Sponsors and Collaborators

      • Assy Nimer

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Assy Nimer, Assy Nimer, Ziv Medical Center, Ziv Hospital
      ClinicalTrials.gov Identifier:
      NCT01735799
      Other Study ID Numbers:
      • 0068-12-ZIV
      First Posted:
      Nov 28, 2012
      Last Update Posted:
      Nov 28, 2012
      Last Verified:
      Nov 1, 2012
      Additional relevant MeSH terms:
      Polycystic Ovary Syndrome
      Liver Diseases
      Fatty Liver
      Non-alcoholic Fatty Liver Disease

      Study Results

      No Results Posted as of Nov 28, 2012