Clinical trial NCT06589167: Metabolic Syndrome and Fatty Liver Disease Among Egyptian Patients with Chronic HBV
Official title: Metabolic Dysfunction Among Egyptian Patients with Chronic HBV
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Metabolic Syndrome
Fatty Liver Disease
Keywords: Metabolic syndrome
Nonalcoholic fatty liver disease
hepatic steatosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: total coverage of all patients with HBV aged 18-60 years,not combined with HCV or HIV.

Brief 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

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.

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.

Primary outcomes:
measure: investigate the Prevalence of combined hepatic steatosis in patients with chronic HBV
timeFrame: baseline
Secondary outcomes:
measure: evaluate clinical characteristics of chronic HBV patients combined with metabolic syndrome and hepatic steatosis
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Hadeer Abd El-Sattar
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Ghadaa Abdel rahman
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Bahaa Osman Taha
role: STUDY_DIRECTOR
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