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THE ASSOCIATION BETWEEN FATTY LIVER (NAFLD) DISEASE AND PCOS

This study is not yet open for participant recruitment.
Verified November 2012 by Ziv Hospital
Sponsor:
Information provided by (Responsible Party):
Assy Nimer, Ziv Hospital
ClinicalTrials.gov Identifier:
NCT01735799
First received: November 25, 2012
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

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
Polycystic Ovarian Syndrome,
Nonalcoholic Fatty Liver Disease

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ziv Hospital:

Study Start Date: November 2012
  Eligibility

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735799

Contacts
Contact: Nimer Assy, MD +972-4-6828445 assy.n@ziv.health.gov.il

Locations
Israel
Liver Clinic, ZIv Medical Center Not yet recruiting
Safed, Israel, 13100
Contact: Nimer Assy, MD     +972-4-6828445     assy.n@ziv.health.gov.il    
Sponsors and Collaborators
Assy Nimer
  More Information

No publications provided

Responsible Party: Assy Nimer, Assy Nimer, Ziv Medical Center, Ziv Hospital
ClinicalTrials.gov Identifier: NCT01735799     History of Changes
Other Study ID Numbers: 0068-12-ZIV
Study First Received: November 25, 2012
Last Updated: November 27, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Polycystic Ovary Syndrome
Digestive System Diseases
Ovarian Cysts
Cysts
 Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013