Effect of Hepatitis C Clearance on Insulin Resistance

NCT04457050 | Completed Phase 4

• 1 other identifier: 020966
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance; Hepatitis C

Outcome Measures

Primary Outcomes (1)

• 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.

  at baseline and 12 weeks after sustained virologic response

Secondary Outcomes (2)

• Prevalence of insulin resistance among hepatitis C patients

  at baseline

• Sustained virologic response

  at 12 weeks after treatment

Study Arms (1)

Non-Diabetic Hepatitis C infected patients

EXPERIMENTAL

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

Interventions

Sofosbuvir 400 milligram DRUG

single daily dose of 400 milligrams

Also known as: Soflanork 400 milligram, Gratisovir 400 milligram

Non-Diabetic Hepatitis C infected patients

Daclatasvir 60 milligram DRUG

single daily dose of 60 milligrams for 12 weeks

Also known as: Daklanork 60 milligram, Daktavira 60 milligram

Non-Diabetic Hepatitis C infected patients

Ribavirin 400 milligram DRUG

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

Also known as: Riba 400 milligram

Non-Diabetic Hepatitis C infected patients

Ledipasvir 90milligram/Sofosbuvir 400 milligram Tab DRUG

single daily dose for 12 weeks

Also known as: HARVONI, Soflanork plus

Non-Diabetic Hepatitis C infected patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hepatitis C treatment-naïve;
• Non-diabetic patients.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine

Alexandria, 21521, Egypt

Location

MeSH Terms

Conditions

Insulin Resistance; Hepatitis C

Interventions

ledipasvir, sofosbuvir drug combination

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine.

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 7, 2020
• Study Start: October 30, 2017
• Primary Completion: November 1, 2019
• Study Completion: December 30, 2019
• Last Updated: July 7, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)