Assiut University hospital
Asyut, 71515, Egypt
NCT Number: NCT03612973
Hepatitis C virus (HCV) is one of the major globally cause of death and morbidity.Chronic hepatitis C is the leading cause of end-stage liver disease, hepatocellular carcinoma and liver-related death in Egypt.It could be considered a special type of metabolic diseases involving insulin resistance (IR) which accelerates fibrosis and modulation of lipid-cholesterol biosynthesis with increased risk for ischemic heart diseases.It could be considered a special type of metabolic diseases involving insulin resistance (IR) which accelerates fibrosis and modulation of lipid-cholesterol biosynthesis with increased risk for ischemic heart diseases .Increased prevalence of IR and type 2 diabetes mellitus extensively reported in HCV infections
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Asyut, 71515, Egypt
Hepatitis C virus (HCV) is one of the major globally cause of death and morbidity and recent estimates showed increase in its prevalence over the last decade to > 185 million infections worldwide. Prevalence HCV infection in Egypt is the highest in the world.Chronic viral hepatitis infection increases liver fibrosis and stiffness and is an important cause of liver cirrhosis. Chronic hepatitis C is the leading cause of end-stage liver disease, hepatocellular carcinoma and liver-related death in Egypt.It could be considered a special type of metabolic diseases involving insulin resistance (IR) which accelerates fibrosis and modulation of lipid-cholesterol biosynthesis with increased risk for ischemic heart diseases .Increased prevalence of IR and type 2 diabetes mellitus extensively reported in HCV infections.Interferon (INF) based therapy was used in chronic HCV patient and investigators reported that it's effective in eradicating HCV RNA and improving liver fibrosis. However, It's associated with several side effects.Novel direct antiviral agents (DAA) for chronic hepatitis C have entered clinical practice. This therapeutics has minimal side effects and achieves sustained virological response (SVR) rates of above 90% of patients and they are shorter and simpler regimens.Liver fibrosis severity assessment is important when staging chronic HCV and it reflects impact of serological viral eradication on hepatic damage and fibrosis. Although liver biopsy is the gold standard procedure for fibrosis assessment, but non-invasive new approaches have been strongly recommended for evaluation of fibrosis, mainly in HCV. They have no complications and have good diagnostic accuracy. One of the most used non-invasive mechanical methods based on ultrasound is transient elastography (Fibro Scan). Although association of baseline metabolic characteristics with treatment outcome has not been fully assessed for DAAs, this group was reported to result in improved rates of SVR and to reduce the predictive ability of these factors except for the baseline low density lipoprotein. The highest prevalence of HCV was reported in Egypt, where genotype 4 is responsible for 91% of infections and DAAs represented main line of treatment in most centers.Although the changes in lipid metabolism after treatment with DAAs were reported for other genotypes. It was not fully studied in genotype 4 infected patients.
Healthy volunteers accepted: No
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Serum samples will be withdrawn after fasting 12 hours then performed on Siemens Dimension Max: Total cholesterol and triglyceride concentrations will be estimated using enzymatic methods ( Roche Diagnostics, Mannheim, Germany). High density lipoprotein cholesterol will be determined after precipitation with phosphotungstic acid/magnesium chloride. Low density lipoprotein(LDL) cholesterol will be measured directly with a commercially available direct LDL-C assay (LDL-C Plus assay; Roche Diagnostics)
serum samples used for doing the test by ELISA after fasting for 8 h
liver stiffness by fibro scan before and after treatment
Time frame: 1 year
by using non-invasive measures (fibro scan) before and after end of treatment (12 weeks0
Time frame: 1 year
changes in values of total cholesterol, triglycerides, LDL and HDL at the baseline and end of treatment (12 weeks)
Time frame: 1 year
measuring fasting insulin and glucose level with calculation of homeostasis model for the assessment of insulin resistance at the baseline and end of treatment (12 weeks)
Assiut University
Other
Assessment of Changes in Liver Fibrosis and Stiffness, Lipid Profile and Insulin Resistance in Patients With Chronic Hepatitis C Viral Infection Who Received Direct Acting Antiviral Therapy
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