Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589167
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
Metabolic Syndrome and Fatty Liver Disease Among Egyptian Patients with Chronic HBV
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Metabolic Dysfunction Among Egyptian Patients with Chronic HBV
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 14 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 47 million premature deaths per year It was the fifth greatest preventable cause of death in 2017 accounting for 84 of all deaths worldwide Egypt ranks 18th with the highest prevalence of obesity in the world447 of adult women and 259 of adult men are living with obesity Egypts obesity prevalence is higher than the regional average of 208 for women and 92 for men
Nonalcoholic fatty liver disease NAFLD is a leading cause of liver disease worldwideThe 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 ie 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 NASHNon 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
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 47 million premature deaths per year It was the fifth greatest preventable cause of death in 2017 accounting for 84 of all deaths worldwide Egypt ranks 18th with the highest prevalence of obesity in the world447 of adult women and 259 of adult men are living with obesity Egypts obesity prevalence is higher than the regional average of 208 for women and 92 for men
Nonalcoholic fatty liver disease NAFLD is a leading cause of liver disease worldwideThe 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 ie 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 NASHNon 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None