Effect of Hepatitis C Clearance on Insulin Resistance

Sponsor

Alexandria University (Other)

Overall Status

Completed

CT.gov ID

NCT04457050

Collaborator

(none)

160

Enrollment

Location

Arm

Actual Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Insulin Resistance Hepatitis C	Drug: Sofosbuvir 400 milligram Drug: Daclatasvir 60 milligram Drug: Ribavirin 400 milligram Drug: Ledipasvir 90milligram/Sofosbuvir 400 milligram Tab	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 30, 2017

Actual Primary Completion Date :

Nov 1, 2019

Actual Study Completion Date :

Dec 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Non-Diabetic Hepatitis C infected patients clinical examination, measurement of weight (Kg), height (meter), and waist circumference (cm). Calculation of the body mass index. Ultrasound abdominal examination. 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. Treatment of all patients with the available generic direct antivirals in Egypt (sofosbuvir/ledipasvir ± ribavirin or sofosbuvir plus daclatasvir ± ribavirin). Evaluation of insulin resistance using the homeostasis model assessment of insulin resistance before and 12 weeks after end of treatment. 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

Arm

Intervention/Treatment

Experimental: Non-Diabetic Hepatitis C infected patients

clinical examination, measurement of weight (Kg), height (meter), and waist circumference (cm). Calculation of the body mass index. Ultrasound abdominal examination. 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. Treatment of all patients with the available generic direct antivirals in Egypt (sofosbuvir/ledipasvir ± ribavirin or sofosbuvir plus daclatasvir ± ribavirin). Evaluation of insulin resistance using the homeostasis model assessment of insulin resistance before and 12 weeks after end of treatment. 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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.