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THE ASSOCIATION BETWEEN FATTY LIVER (NAFLD) DISEASE AND PCOS

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ClinicalTrials.gov Identifier: NCT01735799
Recruitment Status : Unknown
Verified November 2012 by Assy Nimer, Ziv Hospital.
Recruitment status was:  Not yet recruiting
First Posted : November 28, 2012
Last Update Posted : November 28, 2012
Sponsor:
Information provided by (Responsible Party):
Assy Nimer, Ziv Hospital

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
Polycystic Ovarian Syndrome, Nonalcoholic Fatty Liver Disease

Study Type : Observational
Time Perspective: Prospective
Study Start Date : November 2012






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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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


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): 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

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
First Posted: November 28, 2012    Key Record Dates
Last Update Posted: November 28, 2012
Last Verified: November 2012

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