Effect of Hepatitis C Clearance on Insulin Resistance

Hepatitis C Clinical Trial

Official title:

Insulin Resistance and Resistin In Non-Diabetic Patients With Chronic Hepatitis C Before and After Direct-Acting Antiviral Drugs.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04457050
• Other study ID #: 020966
• Status: Completed
• Phase: Phase 4
• Start date: October 30, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: June 2020
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic hepatitis C infection has been linked to insulin resistance, which is the essential component of metabolic syndrome and type 2 diabetes mellitus. Resistin; an adipokine, has been demonstrated to stimulate the secretion of several inflammatory factors known to play a role in the induction of insulin resistance. we investigated the changes in insulin resistance after hepatitis C clearance in the era of direct antivirals.

Description:

the link between hepatitis C infection and insulin resistance has been established. Insuli resistance has been linked to poor response to interferon based therapy. recently, direct acting antiviral drugs are approved for hepatitis C elimination with high potency and safety. The aim of the study is to: 1. Determine the prevalence of insulin resistance among non-diabetic patients with chronic HCV infection. 2. Explore the impact of treatment with DAAs on insulin resistance among chronic HCV infected patients. 3. Investigate the role of insulin resistance as a potential prognostic factor for the response to DAAs. 4. Explore the utility of resistin as a potential biomarker IR among HCV infected patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 30, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Hepatitis C treatment-naïve;

• Non-diabetic patients.

Exclusion Criteria:

• Seropositivity for hepatitis B virus infection;

• Diabetes mellitus;

• Bbody mass index = 30 Kg/M*2;

• History of alcohol consumption;

• Endocrinopathies that may affect the glycemic homeostasis;

• Other known causes of chronic liver disease; Hepatic decompensation [defined as history of gastrointestinal bleeding (melena and /or hematemesis), jaundice, coagulopathy, hepatic encephalopathy, and/or ascites]; bleeding diathesis;

• Connective tissue diseases;

• Autoimmune diseases;

• Cardiac, respiratory or renal disease.

• Patient receiving immuno-modulatory therapy or drugs that affect the blood glucose levels such as steroids or beta-blockers.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Insulin Resistance

Intervention

Drug:
• Sofosbuvir 400 milligram
single daily dose of 400 milligrams
• Daclatasvir 60 milligram
single daily dose of 60 milligrams for 12 weeks
• Ribavirin 400 milligram
weight based dose, 1200 mg for weight > 75 kilogram, and 1000 milligram if weight < 75 kilograms for 12 weeks
• Ledipasvir 90milligram/Sofosbuvir 400 milligram Tab
single daily dose for 12 weeks

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the insulin resistance before and after hepatitis C clearance	Assess the change in the value of Homeostatic Model Assessment for Insulin resistance (Homeostatic Model Assessment for Insulin Resistance) after hepatitis C treatment by calculating the HOMA-IR for all patients at baseline and the re-calculation at 12 weeks after viral clearance to clarify the impact of hepatitis C treatment by direct antiviral drugs on insulin sensitivity.	at baseline and 12 weeks after sustained virologic response
Secondary	Prevalence of insulin resistance among hepatitis C patients	Prevalence of insulin resistance among hepatitis C patients	at baseline
Secondary	Sustained virologic response	Sustained virologic response	at 12 weeks after treatment