Effect of Hepatitis C Clearance on Insulin Resistance

Alexandria University160 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Insulin Resistance Hepatitis C

Interventions

Sofosbuvir 400 milligramDRUG

single daily dose of 400 milligrams

Daclatasvir 60 milligramDRUG

single daily dose of 60 milligrams for 12 weeks

Ribavirin 400 milligramDRUG

weight based dose, 1200 mg for weight \> 75 kilogram, and 1000 milligram if weight \< 75 kilograms for 12 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Medicine

Alexandria, Egypt

Outcomes

Primary Outcomes

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.

Time frame: at baseline and 12 weeks after sustained virologic response

Secondary Outcomes

Prevalence of insulin resistance among hepatitis C patients

Time frame: at baseline

Sustained virologic response

Time frame: at 12 weeks after treatment

Data from ClinicalTrials.gov

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