NCT06589167

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2024

Completed
29 days until next milestone

Study Start

First participant enrolled

September 7, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2025

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

August 9, 2024

Last Update Submit

September 5, 2024

Conditions

Keywords

Metabolic syndromeNonalcoholic fatty liver diseasehepatic steatosis

Outcome Measures

Primary Outcomes (1)

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

    baseline

Secondary Outcomes (1)

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

    baseline

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age above 18 years.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • 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.

    PMID: 35620544BACKGROUND
  • 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.

    PMID: 26622990BACKGROUND
  • 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/

    PMID: 25473721BACKGROUND
  • Swarup S, Ahmed I, Grigorova Y, Zeltser R. Metabolic Syndrome. 2024 Mar 7. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK459248/

    PMID: 29083742BACKGROUND
  • 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.

    PMID: 33075830BACKGROUND
  • 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.

    PMID: 24582089BACKGROUND
  • 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.

    PMID: 34513789BACKGROUND
  • 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.

    PMID: 36517002BACKGROUND
  • 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.

    PMID: 36544761BACKGROUND
  • 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.

    PMID: 36726053BACKGROUND
  • 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.

    PMID: 37770837BACKGROUND
  • 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.

    PMID: 37157776BACKGROUND
  • 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.

    PMID: 36747946BACKGROUND

MeSH Terms

Conditions

Metabolic SyndromeNon-alcoholic Fatty Liver DiseaseFatty Liver

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLiver DiseasesDigestive System Diseases

Study Officials

  • Hadeer Abd El-Sattar

    Assiut University

    PRINCIPAL INVESTIGATOR
  • Ghadaa Abdel rahman

    Assiut University

    STUDY DIRECTOR
  • Bahaa Osman Taha

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Hadeer A Abd El-Sattar

CONTACT

Ghada A Abdel rahman

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

August 9, 2024

First Posted

September 19, 2024

Study Start

September 7, 2024

Primary Completion

September 7, 2025

Study Completion

October 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share