THE ASSOCIATION BETWEEN FATTY LIVER (NAFLD) DISEASE AND PCOS

NCT01735799 | Unknown

• 1 other identifier: 0068-12-ZIV
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovarian Syndrome,; Nonalcoholic Fatty Liver Disease

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Assy Nimer: lead

Study Sites (1)

Liver Clinic, ZIv Medical Center

Safed, 13100, Israel

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Central Study Contacts

Nimer Assy, MD

CONTACT

+972-4-6828445; assy.n@ziv.health.gov.il

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assy Nimer, Ziv Medical Center

Study Record Dates

• First Submitted: November 25, 2012
• First Posted: November 28, 2012
• Study Start: November 1, 2012
• Last Updated: November 28, 2012

Record last verified: 2012-11

Locations

IL (1)