Hepatitis B, ChronicNCT06023745
Study IL- 35 Level and Fibronectin Type Ⅲ Domain Containing Protein 5 \ Irsin (FNDC5 rs3480) Gene Variations in Chronic Hepatitis B.
An observational study of Hepatitis B, Chronic, run by Sohag University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- genotyping
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2023to Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Adult, Older adult
Study population: This study will be conducted on 50 patients 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 (15) A control group of 30 healthy volunteers with negativity for HBsAg, anti- HCV and anti-HIV and with no abnormalities based on physical examination
Who may be able to join
- 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
Who cannot join
- The chronic HBV patients on antiviral therapy will be excluded.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag
Magdy M Amin, professor
About this study
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.
Read the detailed description
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
- Hepatitis B, Chronic
- Being tested
- genotyping
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genotypingGenetic
Genotyping. Measurement of SOD serum level. Measurement of IL-35 serum level.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Genetic: genotyping | |
| control | healthy volunteers with negativity for HBsAg, anti- HCV and anti-HIV and with no abnormalities based on physical examination Receives: Genetic: genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
genotyping of Fibronectin Type Ⅲ Domain Containing Protein 5 \ Irsin (FNDC5 rs3480)
study gene polymorphism of irsin in chronic hepatitis b patients
Measured: 2 months
measure of il 35 in serum
il 35 level in serum of chronic hepatitis b pTIENTS
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start20 Jul 2023
- Primary completion1 Sep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Badway Hemdan, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023745
- Sponsor's protocol ID
- Soh-Med-23-04-11PD
- Status last verified
- Sep 2023
- First submitted
- 17 Jul 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28700046Blackburn 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.
PubMed 20821774Nowinska 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.
PubMed 36430689
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study IL- 35 Level and Fibronectin Type Ⅲ Domain Containing Protein 5 \ Irsin (FNDC5 rs3480) Gene Variations in Chronic Hepatitis B.
- ClinicalTrials.gov ID
- NCT06023745
- Acronym / sponsor ID
- Soh-Med-23-04-11PD
- Conditions
- Hepatitis B, Chronic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case | – | Genetic: genotyping30 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 |
| control | – | Genetic: genotypinghealthy volunteers with negativity for HBsAg, anti- HCV and anti-HIV and with no abnormalities based on physical examination |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted on 50 patients 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 (15) A control group of 30 healthy volunteers with negativity for HBsAg, anti- HCV and anti-HIV and with no abnormalities based on physical examination
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- The chronic HBV patients on antiviral therapy will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genotypingGenotyping. Measurement of SOD serum level. Measurement of IL-35 serum level. | Genetic | case, control |
Primary outcome
genotyping of Fibronectin Type Ⅲ Domain Containing Protein 5 \ Irsin (FNDC5 rs3480)
Time frame: 2 months
study gene polymorphism of irsin in chronic hepatitis b patients
measure of il 35 in serum
Time frame: 2 months
il 35 level in serum of chronic hepatitis b pTIENTS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Background: PubMed 28700046Eskandari 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.
- Background: PubMed 20821774Blackburn 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.
- Background: PubMed 36430689Nowinska 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, Chronic, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shimaa Badawy Hemdan, lecturer (01115894759, shimaabadwy@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
genotyping of Fibronectin Type Ⅲ Domain Containing Protein 5 \ Irsin (FNDC5 rs3480) (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06023745, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.