Study IL- 35 Level and Fibronectin Type Ⅲ Domain Containing Protein 5 \ Irsin (FNDC5 rs3480) Gene Variations in Chronic Hepatitis B.

NCT ID: NCT06023745

Last Updated: 2023-09-05

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

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-20

Study Completion Date

2023-09-30

Brief Summary

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Find a possible association between Fibronectin type Ⅲ domain containing protein 5 \\ Irsin (FNDC5 rs3480) gene single nucleotide polymorphism with chronic hepatitis B and the distribution of its alleles, in relation to many clinical parameters of the chronic hepatitis B group.

* Asses the correlation between IL-35 serum level and the risk of chronic hepatitis B.
* Asses the correlation between SOD serum level and the risk of chronic hepatitis B.

Detailed Description

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Hepatitis B virus (HBV) infection is a serious public health problem worldwide, with approximately 2 billion people having a history of HBV infection and 350 million of them suffering from chronic HBV infection (1).

Although the host factors (such as infection age, gender and immune status), viral and environmental factors are thought to be involved in affecting the development of CHB. The mechanisms underlying the different clinical outcomes of HBV infection have not been fully understood. Studies indicated that host genetic factors play a critical role in the development of HBV infection, especially single nucleotide polymorphisms (SNPs), is regarded to be one of the determinants for this clinical heterogeneity(2,3). Some polymorphisms have been reported to be involved in susceptibility to CHB in disease severity and progression, or disease prognosis (4,5).

Irisin is encoded by the FNDC5 gene, whose expression is controlled by the peroxi- some proliferator activated receptor gamma coactivator 1 alpha (PGC-1α). PGC-1α is a transcriptional co-activator which does not bind directly to DNA. Studies indicated that the estrogen-related receptor alpha (ERRα) could be a factor that plays a role in PGC-1α binding to DNA. ERRα is encoded by the ESRRA gene and is an orphan nuclear receptor, which has two domains. One of them allows the interaction with DNA, and the second one with a ligand. The ERRα structure is similar to that of the estrogen receptor alpha (ERα), but this receptor does not bind to natural estrogens. ERRα interacts with a canonical sequence of the estrogen response elements (ERRE). ERRα and ERα could compete with each other to bind to similar DNA elements. Together, ERRα binds to DNA, in complex with PGC-1α, to regulate the activity of genes such as FNDC5 (6).

Conditions

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Hepatitis B, Chronic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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case

30 patients diagnosed as a clinical disease of CHB according to the diagnostic criteria of CHB based on, HBsAg, HBeAg serostatus ,HBV DNA level, biochemical liver function, and ultrasonography

genotyping

Intervention Type GENETIC

Genotyping. Measurement of SOD serum level. Measurement of IL-35 serum level.

control

healthy volunteers with negativity for HBsAg, anti- HCV and anti-HIV and with no abnormalities based on physical examination

genotyping

Intervention Type GENETIC

Genotyping. Measurement of SOD serum level. Measurement of IL-35 serum level.

Interventions

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genotyping

Genotyping. Measurement of SOD serum level. Measurement of IL-35 serum level.

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* patients diagnosed as a clinical disease of CHB according to the diagnostic criteria of CHB based on, HBsAg, HBeAg serostatus ,HBV DNA level, biochemical liver function, and ultrasonography

Exclusion Criteria

* The chronic HBV patients on antiviral therapy will be excluded.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Shimaa Badway Hemdan

lecturer of medical biochemistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag university Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Shimaa Badawy Hemdan, lecturer

Role: CONTACT

01115894759

Shimaa badawy Hemdan, lecturer

Role: CONTACT

01003079646

Facility Contacts

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Magdy M Amin, professor

Role: primary

References

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Eskandari E, Metanat M, Pahlevani E, Nakhzari-Khodakheir T. Association between TGFbeta1 polymorphisms and chronic hepatitis B infection in an Iranian population. Rev Soc Bras Med Trop. 2017 May-Jun;50(3):301-308. doi: 10.1590/0037-8682-0266-2016.

Reference Type BACKGROUND
PMID: 28700046 (View on PubMed)

Blackburn EH. Telomeres and telomerase: the means to the end (Nobel lecture). Angew Chem Int Ed Engl. 2010 Oct 4;49(41):7405-21. doi: 10.1002/anie.201002387. No abstract available.

Reference Type BACKGROUND
PMID: 20821774 (View on PubMed)

Nowinska K, Jablonska K, Ciesielska U, Piotrowska A, Haczkiewicz-Lesniak K, Pawelczyk K, Podhorska-Okolow M, Dziegiel P. Association of Irisin/FNDC5 with ERRalpha and PGC-1alpha Expression in NSCLC. Int J Mol Sci. 2022 Nov 17;23(22):14204. doi: 10.3390/ijms232214204.

Reference Type BACKGROUND
PMID: 36430689 (View on PubMed)

Other Identifiers

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Soh-Med-23-04-11PD

Identifier Type: -

Identifier Source: org_study_id

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