Effect of Hepatitis C Clearance on Insulin Resistance

Phase 4

Completed

• Conditions: Hepatitis C; Insulin Resistance
• Interventions: Drug: Sofosbuvir 400 milligram; Drug: Daclatasvir 60 milligram; Drug: Ribavirin 400 milligram; Drug: Ledipasvir 90milligram/Sofosbuvir 400 milligram Tab

• Registration Number: NCT04457050
• Lead Sponsor: Alexandria University

Brief 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.

Study Timeline

• Study Start: 2017-10-30
• Primary Completion: 2019-11-01
• Study Completion: 2019-12-30
• Status Verified: 2020-06
• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-06-30
• Last Update Submitted: 2020-06-30
• Study First Posted: 2020-07-07
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non-Diabetic Hepatitis C infected patients	Sofosbuvir 400 milligram	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.
Non-Diabetic Hepatitis C infected patients	Daclatasvir 60 milligram	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.
Non-Diabetic Hepatitis C infected patients	Ribavirin 400 milligram	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.
Non-Diabetic Hepatitis C infected patients	Ledipasvir 90milligram/Sofosbuvir 400 milligram Tab	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.

Primary Outcome Measures

Name	Time	Method
Change in the insulin resistance before and after hepatitis C clearance	at baseline and 12 weeks after sustained virologic response	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.

Secondary Outcome Measures

Name	Time	Method
Prevalence of insulin resistance among hepatitis C patients	at baseline	Prevalence of insulin resistance among hepatitis C patients
Sustained virologic response	at 12 weeks after treatment	Sustained virologic response

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Alexandria, Egypt