Menu
Not yet recruiting NCT06589167

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

Observational Metabolic Syndrome Fatty Liver Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Metabolic Syndrome, Fatty Liver Disease. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Metabolic Dysfunction Among Egyptian Patients with Chronic HBV

Overview

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

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.

Primary outcome measures

  • investigate the Prevalence of combined hepatic steatosis in patients with chronic HBV [Time frame: baseline]
Secondary outcome measures (1)
  • evaluate clinical characteristics of chronic HBV patients combined with metabolic syndrome and hepatic steatosis [Time frame: baseline]

Eligibility criteria

Inclusion criteria

  • Age above 18 years.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 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. PMID 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/ PMID 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/ PMID 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. PMID 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. PMID 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. PMID 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. PMID 36517002

Identifiers

NCT: NCT06589167 · Metabolic syndrome and NAFLD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗