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Completed

NCT Number: NCT04457050

Effect of Hepatitis C Clearance on Insulin Resistance

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine

Alexandria, 21521, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sofosbuvir 400 milligram

Drug

single daily dose of 400 milligrams

Other names: Soflanork 400 milligram, Gratisovir 400 milligram

Daclatasvir 60 milligram

Drug

single daily dose of 60 milligrams for 12 weeks

Other names: Daklanork 60 milligram, Daktavira 60 milligram

Ribavirin 400 milligram

Drug

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

Other names: Riba 400 milligram

Ledipasvir 90milligram/Sofosbuvir 400 milligram Tab

Drug

single daily dose for 12 weeks

Other names: HARVONI, Soflanork plus

Primary outcomes

  1. 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.

Secondary outcomes

  1. Prevalence of insulin resistance among hepatitis C patients

    Time frame: at baseline

    Prevalence of insulin resistance among hepatitis C patients

  2. Sustained virologic response

    Time frame: at 12 weeks after treatment

    Sustained virologic response

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 7, 2020
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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