Effect of Hepatitis C Clearance on Insulin Resistance

June 30, 2020 updated by: Sameh A. Lashen, Alexandria University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21521
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-Diabetic Hepatitis C infected patients
  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.
Drug: Sofosbuvir 400 milligram
single daily dose of 400 milligrams
Other Names:
  • Soflanork 400 milligram
  • Gratisovir 400 milligram
Drug: Daclatasvir 60 milligram
single daily dose of 60 milligrams for 12 weeks
Other Names:
  • Daklanork 60 milligram
  • Daktavira 60 milligram
Drug: Ribavirin 400 milligram
weight based dose, 1200 mg for weight > 75 kilogram, and 1000 milligram if weight < 75 kilograms for 12 weeks
Other Names:
  • Riba 400 milligram
Drug: Ledipasvir 90milligram/Sofosbuvir 400 milligram Tab
single daily dose for 12 weeks
Other Names:
  • HARVONI
  • Soflanork plus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the insulin resistance before and after hepatitis C clearance
Time Frame: 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.
at baseline and 12 weeks after sustained virologic response

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of insulin resistance among hepatitis C patients
Time Frame: at baseline
Prevalence of insulin resistance among hepatitis C patients
at baseline
Sustained virologic response
Time Frame: at 12 weeks after treatment
Sustained virologic response
at 12 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2017

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

June 29, 2020

First Submitted That Met QC Criteria

June 30, 2020

First Posted (Actual)

July 7, 2020

Study Record Updates

Last Update Posted (Actual)

July 7, 2020

Last Update Submitted That Met QC Criteria

June 30, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 020966

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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