Effect of Hepatitis C Clearance on Insulin Resistance

Alexandria University

Status and phase: Completed; Phase 4

Conditions: Hepatitis C; Insulin Resistance

Treatments: Drug: Sofosbuvir 400 milligram; Drug: Ledipasvir 90milligram/Sofosbuvir 400 milligram Tab; Drug: Ribavirin 400 milligram; Drug: Daclatasvir 60 milligram

Study type: Interventional

Funder types: Other

Identifiers

NCT04457050

020966

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

Non-Diabetic Hepatitis C infected patients

Experimental group

Description:

1. clinical examination, 2. measurement of weight (Kg), height (meter), and waist circumference (cm). 3. Calculation of the body mass index. 4. Ultrasound abdominal examination. 5. Laboratory Investigations including Complete blood count, Serum aspartate and alanine aminotransferases, serum albumin, serum bilirubin, serum gamma-glutamyl transpeptidase, and international normalization ratio. HCV-RNA quantification before treatment and 12 weeks after the end of therapy.. Serum lipid profile, fasting and post-prandial blood sugar, glycated hemoglobin A1c also included. 6. Treatment of all patients with the available generic direct antivirals in Egypt (sofosbuvir/ledipasvir ± ribavirin or sofosbuvir plus daclatasvir ± ribavirin). 7. Evaluation of insulin resistance using the homeostasis model assessment of insulin resistance before and 12 weeks after end of treatment. 8. measurement of serum levels of resistin before and at 12 weeks after treatment.

Treatment:

Drug: Daclatasvir 60 milligram

Drug: Ribavirin 400 milligram

Drug: Ledipasvir 90milligram/Sofosbuvir 400 milligram Tab

Drug: Sofosbuvir 400 milligram