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THE ASSOCIATION BETWEEN FATTY LIVER (NAFLD) DISEASE AND PCOS

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Ziv Hospital.
Recruitment status was  Not yet recruiting
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

November 25, 2012
November 27, 2012
November 2012
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Complete list of historical versions of study NCT01735799 on ClinicalTrials.gov Archive Site
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THE ASSOCIATION BETWEEN FATTY LIVER (NAFLD) DISEASE AND PCOS
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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.

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Observational
Time Perspective: Prospective
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Non-Probability Sample

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.

  • Polycystic Ovarian Syndrome,
  • Nonalcoholic Fatty Liver Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
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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

Female
18 Years to 50 Years
No
Contact: Nimer Assy, MD +972-4-6828445 assy.n@ziv.health.gov.il
Israel
 
NCT01735799
0068-12-ZIV
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Assy Nimer, Ziv Hospital
Assy Nimer
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Ziv Hospital
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP