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The Connection Between Liver Disease and Chitinase Proteins

NCT ID: NCT00852293

Last Updated: 2009-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2014-03-31

Brief Summary

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Chitinase and chitinase like proteins are members of the 18-glycosyl-hydrolase family. Several reports have linked the chitinase 3 like 1 protein with colitis, asthma and liver disease.

This study aims to evaluate the correlation of chitinase 3 like 1 protein with clinical parameters such as disease severity, reaction to treatment, portal hypertension and prognosis.

Detailed Description

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Chitin is a poly saccharide, abundant in insects, fungi, crustaceans and other organisms, but not in mammals. Chitinases and chitinase like proteins (which have the ability to bind chitin without enzymatic activity) are members of the 18-glycosyl-hydrolase family. Their function and importance are still not clearly understood. However, several reports have linked the chitinase 3 like 1 protein with colitis and asthma. Furthermore, Johansen et al have reported elevated levels of chitinase 3 like 1 protein in patients with liver disease, mainly those with alcoholic liver disease (ALD) and fibrosis. This report consisted of 51 patients with ALD ,but only 16 and 17 patients with fatty liver and viral hepatitis respectively.

This study aims to evaluate the correlation of chitinase 3 like 1 protein with clinical parameters such as disease severity, reaction to treatment, portal hypertension (when measured) and prognosis.

\*\*\*Study design:

a. Subjects i.The study will include patients with liver disease followed at the liver unit, Hadassah Medical Center, Jerusalem. b. Planned number i.The study is planned to include 200 volunteers. c. Inclusion criteria i.Patients with liver disease followed at the liver unit at Hadassah Medical Center. ii.Patients who have given their informed consent for participation in the study. d. Exclusion criteria i.Age\<18y. ii.Pregnancy iii.Patients with other conditions associated with elevated chitinase 3 like 1 protein (such as asthma and rheumatoid arthritis). e. Chitinase 3 like-1 protein levels will be measured by a commercially available kit (Human Chitinase 3-like 1 Quantikine ELISA Kit, catalogue number - DC3L1, Biotest LTD). f. Stopping/modifying criteria i.At subjects' request. g. Trial entry and enrollment i.A consecutive cohort will be recruited form amongst the patients followed at the liver unit in Hadassah medical center. Jerusalem Israel. ii.Consenting patients will have a blood test drawn for chitinase 3 like 1 protein levels. iii.Clinical details of each patient will be obtained form the liver unit. iv.In addition to the routine follow up at the liver unit, follow up will be performed at 1,2 and 5 years. h. Statistical considerations i.Subjects will be grouped according to their clinical properties (disease, treatment, severity, portal hypertension) ii.Chitinase 3 like 1 protein levels will be compared between each group. F. Informed consent i.Each subject will be enrolled and enter the study only after giving an informed consent. G. Adherence to study eligibility i.The study will be conducted in accordance with good clinical practice (GCP) guidelines, and the study protocol. H. Safeguarding of documents i.The privacy of the subjects and all confidentiality issues will be handled in accordance with applicable law and guidelines of the institution and the Helsinki Committee, the Israeli ministry of health, or the other appropriate regulatory authorities.

Conditions

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Liver Disease

Keywords

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liver disease Chitinase 3 like-1 protein

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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study group

Patients with liver disease followed at the liver unit at Hadassah Medical Center.

A blood test

Intervention Type OTHER

A blood test of about 5ml of blood will be taken to determine Chitinase 3 like-1 protein levels.

Interventions

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A blood test

A blood test of about 5ml of blood will be taken to determine Chitinase 3 like-1 protein levels.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with liver disease followed at the liver unit at Hadassah Medical Center.
* Patients who have given their informed consent for participation in the study

Exclusion Criteria

* Age\<18y.
* Pregnancy
* Patients with other conditions associated with elevated chitinase 3 like 1 protein (such as asthma and rheumatoid arthritis).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Hadassah Hebrew University Medical Center

Locations

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Hadassah Medical Organization,

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Arik Tzukert, DMD

Role: CONTACT

Phone: 00 972 2 6776095

Email: [email protected]

Hadas Lemberg, PhD

Role: CONTACT

Phone: 00 972 2 6777572

Email: [email protected]

Facility Contacts

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Arik Tzukert, DMD

Role: primary

Hadas Lemberg, PhD

Role: backup

References

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Kawada M, Hachiya Y, Arihiro A, Mizoguchi E. Role of mammalian chitinases in inflammatory conditions. Keio J Med. 2007 Mar;56(1):21-7. doi: 10.2302/kjm.56.21.

Reference Type BACKGROUND
PMID: 17392594 (View on PubMed)

Chupp GL, Lee CG, Jarjour N, Shim YM, Holm CT, He S, Dziura JD, Reed J, Coyle AJ, Kiener P, Cullen M, Grandsaigne M, Dombret MC, Aubier M, Pretolani M, Elias JA. A chitinase-like protein in the lung and circulation of patients with severe asthma. N Engl J Med. 2007 Nov 15;357(20):2016-27. doi: 10.1056/NEJMoa073600.

Reference Type BACKGROUND
PMID: 18003958 (View on PubMed)

Johansen JS, Christoffersen P, Moller S, Price PA, Henriksen JH, Garbarsch C, Bendtsen F. Serum YKL-40 is increased in patients with hepatic fibrosis. J Hepatol. 2000 Jun;32(6):911-20. doi: 10.1016/s0168-8278(00)80095-1.

Reference Type BACKGROUND
PMID: 10898311 (View on PubMed)

Other Identifiers

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481132-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id