A Potential Novel Marker for Liver Fibrosis in NASH: the Soluble Secreted Form of the Human Asialoglycoprotein Receptor

This study has been completed.
Sponsor:
Information provided by:
Ziv Hospital
ClinicalTrials.gov Identifier:
NCT00941902
First received: July 16, 2009
Last updated: May 16, 2011
Last verified: May 2011
  Purpose

Soluble secreted proteins that are expressed uniquely in specific organs and whose formation of secretion is regulated by disease states are excellent markers for the disease. This is because the disease can be diagnosed by simply measuring the levels of the secreted protein in serum. A soluble form of the asialoglycoprotein receptor could be a promising candidate for such marker in the case of liver fibrosis secondary to steatohepatitis for which the existing markers are not satisfactory. The human asialoglycoprotein receptor (ASGPR) is expressed only in hepatocytes. The H2a alternatively spliced variant of the ASGPR H2 subunit differs from H2b variant only by the presence of an extra pentapeptide. EGHRG, in the exoplasmic domain next to the membrane-spanning segment. H2a is rapidly cleaved to a36 kDa fragment, comprising the entire ectodomain, which is secreted. H2a does not participate in a membrane bound receptor complex with H1 as in the case for H2b and thus it is not a subunit of the receptor but a precursor for a soluble secreted form of the protein (sH2a). Although H2a is a type II transmembrane protein, signal peptidase is probably responsible for the cleavage to the soluble form.

The objective in this research proposal is to study the association between the level of sH2a. in the serum and the severity of fibrosis in steatohepatitis in patients undergoing bariatric surgery due to morbid obesity.

The existence of sH2a in normal human serum is at very constant levels. On the other hand the membrane ASGPR (expressed exclusively in hepatocytes) is profoundly down - regulated in liver cancer and cirrhosis. The investigators will analyze the levels of sH2a in serum from patients with steatohepatitis in different stages of fibrosis and compare with healthy subjects. A possible early down-regulation of sH2a in fibrosis may prove to be a valuable diagnostic tool.


Condition
Liver Fibrosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: A Potential Novel Marker for Liver Fibrosis in Nonalcoholic Steatohepatitis: the Soluble Secreted Form of the Human Asialoglycoprotein Receptor Non-interventional Study.

Resource links provided by NLM:


Further study details as provided by Ziv Hospital:

Enrollment: 148
Study Start Date: May 2009
Study Completion Date: February 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients scheduled to bariatric surgery

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who are scheduled to bariatric surgery will be enrolled.

Criteria

Inclusion Criteria:

  1. Signed informed consent.
  2. Patient candidate to bariatric surgery.

Exclusion Criteria:

  1. Liver biopsy during the last 12 months.
  2. The surgeon consider liver biopsy as a special dander in a specific patient.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00941902

Locations
Israel
ZIV Medical Center
Safed, Israel, 13110
Sponsors and Collaborators
Ziv Hospital
Investigators
Principal Investigator: Osamah Hussein, MD Ziv Medical Center
  More Information

No publications provided

Responsible Party: Dr. Hussein Osamah, Ziv Medical Center
ClinicalTrials.gov Identifier: NCT00941902     History of Changes
Other Study ID Numbers: 0022-09 ZIV
Study First Received: July 16, 2009
Last Updated: May 16, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by Ziv Hospital:
human asialoglycoprotein receptor (ASGPR)
hepatocytes
bariatric surgery

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 23, 2014