AzTrials
AzTrials

Metabolic SyndromeNCT06589167

Metabolic Syndrome and Fatty Liver Disease Among Egyptian Patients with Chronic HBV

An observational study of Metabolic Syndrome and Fatty Liver Disease, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

1. investigate the Prevalence of combined hepatic steatosis in patients with chronic HBV. 2. to evaluate clinical characteristics of chronic HBV patients combined with metabolic syndrome and hepatic steatosis Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Metabolic Syndrome, Fatty Liver Disease
How many people
100 participants
Where
No sites listed yet
Study dates
7 Sep 2024to Oct 2025
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: total coverage of all patients with HBV aged 18-60 years,not combined with HCV or HIV.

Who may be able to join

  • Age above 18 years.

Who cannot join

  • Age below 18 years.
  • Patients with combined HBV,HCV,HIV.
  • Patients refused to contribute in this study.

Trial locations and contacts

No sites are listed yet.

Hadeer A Abd El-Sattar contact

01025454235

mohammedhadeer101@gmail.com

Ghada A Abdel rahman contact

01004301177

ghadaa1980@aun.edu.eg

About this study

Official title: Metabolic Dysfunction Among Egyptian Patients with Chronic HBV

  1. investigate the Prevalence of combined hepatic steatosis in patients with chronic HBV.
  2. to evaluate clinical characteristics of chronic HBV patients combined with metabolic syndrome and hepatic steatosis
Read the detailed description
  • Hepatitis B virus (HBV) infection is a major global health problem, with an estimated 290 million infections worldwide. The estimated prevalence of HBV is about 1.4% in Egypt.
  • Chronic hepatitis B describes a spectrum of disease usually characterised by the presence of detectable hepatitis B surface antigen (HbsAg) in the blood or serum for longer than 6 months. In some people, chronic hepatitis B is inactive and does not present significant health problems, but others may progress to liver fibrosis, cirrhosis and hepatocellular carcinoma (HCC). The progression of liver disease is associated with hepatitis B virus (HBV) DNA levels in the blood. The presence of HbeAg is typically associated with higher rates of viral replication and therefore increased infectivity.
  • Metabolic syndrome is an accumulation of several disorders that includes central obesity, insulin resistance, hypertension, and atherogenic dyslipidemia .These disorders raise the risk of atherosclerotic cardiovascular disease, including myocardial infarction, cerebrovascular accidents, peripheral vascular diseases, insulin resistance, and type II diabetes mellitus.
  • Obesity causes an estimated 4.7 million premature deaths per year. It was the fifth greatest preventable cause of death in 2017, accounting for 8.4% of all deaths worldwide. Egypt ranks 18th with the highest prevalence of obesity in the world.44.7% of adult women and 25.9% of adult men are living with obesity. Egypt's obesity prevalence is higher than the regional average of 20.8% for women and 9.2% for men.
  • Nonalcoholic fatty liver disease (NAFLD) is a leading cause of liver disease worldwide.The estimated global prevalence of NAFLD among adults is 32% and is higher among males (40%) compared to females (26%) .NAFLD is defined as the presence of steatosis (i.e. more than 5% liver fat content) without coexisting etiologies of secondary steatosis such as alcohol abuse and drug-induced liver injury .
  • Dysregulated fatty acid metabolism and lipotoxicity in NAFLD disease initiate activation of signaling pathways that enhance pro-inflammatory responses and disrupt hepatocyte cell homeostasis, promoting progression of NAFLD disease to NASH(Non Alcoholic Steatohepatitis), fibrosis and HCC and can affect HBV replication and immune encountering of HBV virus, which may further have impact on liver disease progression .Chronic HBV infection is suggested to have an influence on metabolic changes, which could lead to NAFLD development and the HBV-induced inflammatory responses and molecular pathways may constitute an aggravating factor in hepatic steatosis development. The altered immune homeostasis in both HBV infection and NAFLD could be associated with progression to HCC development.
Keywords
Metabolic syndrome, Nonalcoholic fatty liver disease, hepatic steatosis
Medical subject headings
Metabolic Syndrome, Non-alcoholic Fatty Liver Disease, Fatty Liver

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. investigate the Prevalence of combined hepatic steatosis in patients with chronic HBV

    Measured: baseline

Secondary outcomes (1)

  1. evaluate clinical characteristics of chronic HBV patients combined with metabolic syndrome and hepatic steatosis

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start7 Sep 2024 (estimated)
  3. Primary completion7 Sep 2025 (estimated)
  4. Study completionOct 2025 (estimated)

Resources

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
Other
Time perspective
Cross-sectional
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06589167
Sponsor's protocol ID
Metabolic syndrome and NAFLD
Status last verified
Aug 2024
First submitted
9 Aug 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mohammed H, Eshetie A, Melese D. Prevalence of hepatitis B virus and associated risk factors among adults patients at Dessie referral and Kemise general hospitals in northeastern Ethiopia. Health Sci Rep. 2022 May 22;5(3):e659. doi: 10.1002/hsr2.659. eCollection 2022 May.

    PubMed 35620544

  • Bhat M, Ghali P, Deschenes M, Wong P. Prevention and Management of Chronic Hepatitis B. Int J Prev Med. 2014 Dec;5(Suppl 3):S200-7.

    PubMed 26622990

  • National Clinical Guideline Centre (UK). Hepatitis B (Chronic): Diagnosis and Management of Chronic Hepatitis B in Children, Young People and Adults. London: National Institute for Health and Care Excellence (UK); 2013 Jun. Available from http://www.ncbi.nlm.nih.gov/books/NBK254250/

    PubMed 25473721

  • Swarup S, Ahmed I, Grigorova Y, Zeltser R. Metabolic Syndrome. 2024 Mar 7. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK459248/

    PubMed 29083742

  • Bovolini A, Garcia J, Andrade MA, Duarte JA. Metabolic Syndrome Pathophysiology and Predisposing Factors. Int J Sports Med. 2021 Mar;42(3):199-214. doi: 10.1055/a-1263-0898. Epub 2020 Oct 19.

    PubMed 33075830

  • Samson SL, Garber AJ. Metabolic syndrome. Endocrinol Metab Clin North Am. 2014 Mar;43(1):1-23. doi: 10.1016/j.ecl.2013.09.009.

    PubMed 24582089

  • Aboulghate M, Elaghoury A, Elebrashy I, Elkafrawy N, Elshishiney G, Abul-Magd E, Bassiouny E, Toaima D, Elezbawy B, Fasseeh A, Abaza S, Voko Z. The Burden of Obesity in Egypt. Front Public Health. 2021 Aug 27;9:718978. doi: 10.3389/fpubh.2021.718978. eCollection 2021.

    PubMed 34513789

  • Teng ML, Ng CH, Huang DQ, Chan KE, Tan DJ, Lim WH, Yang JD, Tan E, Muthiah MD. Global incidence and prevalence of nonalcoholic fatty liver disease. Clin Mol Hepatol. 2023 Feb;29(Suppl):S32-S42. doi: 10.3350/cmh.2022.0365. Epub 2022 Dec 14.

    PubMed 36517002

  • Tourkochristou E, Assimakopoulos SF, Thomopoulos K, Marangos M, Triantos C. NAFLD and HBV interplay - related mechanisms underlying liver disease progression. Front Immunol. 2022 Dec 5;13:965548. doi: 10.3389/fimmu.2022.965548. eCollection 2022.

    PubMed 36544761

  • Huang SC, Liu CJ. Chronic hepatitis B with concurrent metabolic dysfunction-associated fatty liver disease: Challenges and perspectives. Clin Mol Hepatol. 2023 Apr;29(2):320-331. doi: 10.3350/cmh.2022.0422. Epub 2023 Feb 1.

    PubMed 36726053

  • Dai YN, Xu CF, Pan HY, Chen MJ, Yu CH. Fatty liver is associated with significant liver inflammation and increases the burden of advanced fibrosis in chronic HBV infection. BMC Infect Dis. 2023 Sep 28;23(1):637. doi: 10.1186/s12879-023-08632-y.

    PubMed 37770837

  • Wong YJ, Nguyen VH, Yang HI, Li J, Le MH, Wu WJ, Han NX, Fong KY, Chen E, Wong C, Rui F, Xu X, Xue Q, Hu XY, Leow WQ, Goh GB, Cheung R, Wong G, Wong VW, Yu MW, Nguyen MH. Impact of fatty liver on long-term outcomes in chronic hepatitis B: a systematic review and matched analysis of individual patient data meta-analysis. Clin Mol Hepatol. 2023 Jul;29(3):705-720. doi: 10.3350/cmh.2023.0004. Epub 2023 May 8.

    PubMed 37157776

  • Liu L, Li H, Zhang Y, Zhang J, Cao Z. Hepatitis B virus infection combined with nonalcoholic fatty liver disease: Interaction and prognosis. Heliyon. 2023 Jan 20;9(1):e13113. doi: 10.1016/j.heliyon.2023.e13113. eCollection 2023 Jan.

    PubMed 36747946

Questions about this trial

What is this clinical trial studying?

An observational study of Metabolic Syndrome and Fatty Liver Disease, run by Assiut University.

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 3 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

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 Hadeer A Abd El-Sattar (01025454235, mohammedhadeer101@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

investigate the Prevalence of combined hepatic steatosis in patients with chronic HBV (time frame: baseline). 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 NCT06589167, which also lists 13 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 19 Sep 2024.

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