NCT04457050

Effect of Hepatitis C Clearance on Insulin Resistance

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Insulin Resistance
• Hepatitis C

Interventions

Type	Name	Description
DRUG	Sofosbuvir 400 milligram	single daily dose of 400 milligrams
DRUG	Daclatasvir 60 milligram	single daily dose of 60 milligrams for 12 weeks
DRUG	Ribavirin 400 milligram	weight based dose, 1200 mg for weight \> 75 kilogram, and 1000 milligram if weight \< 75 kilograms for 12 weeks
DRUG	Ledipasvir 90milligram/Sofosbuvir 400 milligram Tab	single daily dose for 12 weeks

Timeline

• Start date: 2017-10-30
• Primary completion: 2019-11-01
• Completion: 2019-12-30
• First posted: 2020-07-07
• Last updated: 2020-07-07

Locations

1 site across 1 country: Egypt