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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04457050
Other study ID # 020966
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 30, 2017
Est. completion date December 30, 2019

Study information

Verified date June 2020
Source Alexandria University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date December 30, 2019
Est. primary completion date November 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Sofosbuvir 400 milligram
single daily dose of 400 milligrams
Daclatasvir 60 milligram
single daily dose of 60 milligrams for 12 weeks
Ribavirin 400 milligram
weight based dose, 1200 mg for weight > 75 kilogram, and 1000 milligram if weight < 75 kilograms for 12 weeks
Ledipasvir 90milligram/Sofosbuvir 400 milligram Tab
single daily dose for 12 weeks

Locations

Country Name City State
Egypt Faculty of Medicine Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Prevalence of insulin resistance among hepatitis C patients Prevalence of insulin resistance among hepatitis C patients at baseline
Secondary Sustained virologic response Sustained virologic response at 12 weeks after treatment
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