Impact of Insulin Resistance on Therapeutic Response for Oral Treatment of Chronic Hepatitis C Virus Infection

Globally, approximately 170 million people are infected with hepatitis C virus (HCV); 350,000 deaths each year are caused by HCV infection (Perz,et al, 2006).The Egyptian Demographic Health Survey (EDHS), across sectional survey including hepatitis C virus (HCV)biomarkers, was conducted in 2008 on a large nationally representative sample (El-Zanaty F, et al 2009). It estimated HCV prevalence among the 15-59 years age group to be 14.7% (El-Zanaty F, et al 2009).Accordingly, Egypt has the highest HCV prevalence in the world (Lavanchy D, 2011), ( Shepard CW,et al 2005)..Interferon (INF)-free regimens of combined directly acting antivirals (DAAs) have shown improved efficacy and tolerability compared with interferon (IFN)-containing regimens, and they have become the standard of care for treatment of HCV genotype-1 (HCV-1)(Afdhal, et al, 2014).Insulin resistance is a state in which a given concentration of insulin produces a less-than-expected biological effect. The prevalence of type 2 diabetes mellitus in hepatitis C in cirrhotic patients is 27.3% which is higher than among non-cirrhotic hepatitis C patients (17.5%)(Romero-Gómez, 2006). HCV promotes insulin resistance and insulin resistance induces interferon resistance, steatosis and fibrosis progression in a genotype-dependent manner.In HCV-1, insulin resistance decreases sustained response rate, and increase the risk for the development of steatosis and fibrosis progression, However, the impact of insulin resistance in other genotypes seems not achieve enough importance to impair sustained response, probably due to the high sensitivity to peginterferon. The treatment of insulin resistance, decreasing hyperinsulinemia, could improve sustained response rate in patients with chronic HCV-1 infection when treated with peginterferon plus ribavirin(Romero-Gómez,2006).

Objectives: we aim to determine the prevalence of insulin resistance among the patients with chronic hepatitis C virus( HCV) infection and to explore the association between insulin resistance and therapeutic response by comparing the insulin resistance among responders and non-responders to oral treatment of chronic hepatitis C virus infection Patients and methods: The study is intended to include patients of chronic hepatitis C virus infection receiving oral treatment for one year period. All patients will have clinical evaluation, ultrasonographic examination, and laboratory investigations which include complete blood count, liver function tests, estimation of fasting serum glucose, fasting serum insulin, and determination of insulin resistance index.The patients will be selected according the selection criteria determined by the National Committee for Control of Viral Hepatitis (NCCVH).

Study Overview

• Status: Unknown
• Conditions: Hepatitis C
• Intervention / Treatment: Diagnostic test: fasting serum insulin

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Assiut University
    • Contact: Rasha H Sayed, master; Phone Number: 00201093241729; Email: rashrusha@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with chronic HCV infection

Description

Inclusion Criteria:

• The study is intended to include patients with chronic HCV infection.

Exclusion Criteria:

• Presence of large risky esophageal varices (except after successful prophylactic banding).
• Uncontrolled ascites.
• Patients with hepatocellular carcinoma except after successful curative intervention (3 months after resection or successful loco-regional therapy).
• Child score of 8 or less.
• Total serum bilirubin of 5 mg/dL or less.
• Platelet count of 30000/mm3 or more.
• Hemoglobin level of 10 g/DL or more.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fasting serum insulin	which is estimated fasting serum insulin in micro international unit per millileter	10 minutes

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: July 7, 2017
• First Submitted That Met QC Criteria: July 7, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 7, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; RNA Virus Infections; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hyperinsulinism; Hepatitis; Hepatitis A; Hepatitis C; Virus Diseases; Insulin Resistance; Hepatitis C, Chronic; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: 17200093

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No