Back to resultsEffect of Hepatitis C Clearance on Insulin Resistance
Primary Purpose
Insulin Resistance, Hepatitis C
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Sofosbuvir 400 milligram
Daclatasvir 60 milligram
Ribavirin 400 milligram
Ledipasvir 90milligram/Sofosbuvir 400 milligram Tab
Sponsored by
About this trial
This is an interventional treatment trial for Insulin Resistance
Eligibility Criteria
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.
Sites / Locations
- Faculty of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Non-Diabetic Hepatitis C infected patients
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Prevalence of insulin resistance among hepatitis C patients
Prevalence of insulin resistance among hepatitis C patients
Sustained virologic response
Sustained virologic response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04457050
Brief Title
Effect of Hepatitis C Clearance on Insulin Resistance
Official Title
Insulin Resistance and Resistin In Non-Diabetic Patients With Chronic Hepatitis C Before and After Direct-Acting Antiviral Drugs.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
October 30, 2017 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
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
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-Diabetic Hepatitis C infected patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir 400 milligram
Other Intervention Name(s)
Soflanork 400 milligram, Gratisovir 400 milligram
Intervention Description
single daily dose of 400 milligrams
Intervention Type
Drug
Intervention Name(s)
Daclatasvir 60 milligram
Other Intervention Name(s)
Daklanork 60 milligram, Daktavira 60 milligram
Intervention Description
single daily dose of 60 milligrams for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Ribavirin 400 milligram
Other Intervention Name(s)
Riba 400 milligram
Intervention Description
weight based dose, 1200 mg for weight > 75 kilogram, and 1000 milligram if weight < 75 kilograms for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Ledipasvir 90milligram/Sofosbuvir 400 milligram Tab
Other Intervention Name(s)
HARVONI, Soflanork plus
Intervention Description
single daily dose for 12 weeks
Primary Outcome Measure Information:
Title
Change in the insulin resistance before and after hepatitis C clearance
Description
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.
Time Frame
at baseline and 12 weeks after sustained virologic response
Secondary Outcome Measure Information:
Title
Prevalence of insulin resistance among hepatitis C patients
Description
Prevalence of insulin resistance among hepatitis C patients
Time Frame
at baseline
Title
Sustained virologic response
Description
Sustained virologic response
Time Frame
at 12 weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Medicine
City
Alexandria
ZIP/Postal Code
21521
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Hepatitis C Clearance on Insulin Resistance
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