Clinical trial NCT03212833: Impact of Insulin Resistance on Therapeutic Response for Oral Treatment of Chronic Hepatitis C Virus Infection
Official title: Impact of Insulin Resistance on Therapeutic Response for Oral Treatment of Chronic Hepatitis C Virus Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with chronic HCV infection

Brief summary: Globally, approximately 170 million people are infected with hepatitis C virus (HCV); 350,000 deaths each year are caused by HCV infection (Perz,et al, 2006).The Egyptian Demographic Health Survey (EDHS), across sectional survey including hepatitis C virus (HCV)biomarkers, was conducted in 2008 on a large nationally representative sample (El-Zanaty F, et al 2009). It estimated HCV prevalence among the 15-59 years age group to be 14.7% (El-Zanaty F, et al 2009).Accordingly, Egypt has the highest HCV prevalence in the world (Lavanchy D, 2011), ( Shepard CW,et al 2005)..Interferon (INF)-free regimens of combined directly acting antivirals (DAAs) have shown improved efficacy and tolerability compared with interferon (IFN)-containing regimens, and they have become the standard of care for treatment of HCV genotype-1 (HCV-1)(Afdhal, et al, 2014).Insulin resistance is a state in which a given concentration of insulin produces a less-than-expected biological effect. The prevalence of type 2 diabetes mellitus in hepatitis C in cirrhotic patients is 27.3% which is higher than among non-cirrhotic hepatitis C patients (17.5%)(Romero-Gómez, 2006). HCV promotes insulin resistance and insulin resistance induces interferon resistance, steatosis and fibrosis progression in a genotype-dependent manner.In HCV-1, insulin resistance decreases sustained response rate, and increase the risk for the development of steatosis and fibrosis progression, However, the impact of insulin resistance in other genotypes seems not achieve enough importance to impair sustained response, probably due to the high sensitivity to peginterferon. The treatment of insulin resistance, decreasing hyperinsulinemia, could improve sustained response rate in patients with chronic HCV-1 infection when treated with peginterferon plus ribavirin(Romero-Gómez,2006).

Objectives: we aim to determine the prevalence of insulin resistance among the patients with chronic hepatitis C virus( HCV) infection and to explore the association between insulin resistance and therapeutic response by comparing the insulin resistance among responders and non-responders to oral treatment of chronic hepatitis C virus infection Patients and methods: The study is intended to include patients of chronic hepatitis C virus infection receiving oral treatment for one year period. All patients will have clinical evaluation, ultrasonographic examination, and laboratory investigations which include complete blood count, liver function tests, estimation of fasting serum glucose, fasting serum insulin, and determination of insulin resistance index.The patients will be selected according the selection criteria determined by the National Committee for Control of Viral Hepatitis (NCCVH).


Eligibility criteria: Inclusion Criteria:

* The study is intended to include patients with chronic HCV infection.

Exclusion Criteria:

* Presence of large risky esophageal varices (except after successful prophylactic banding).
* Uncontrolled ascites.
* Patients with hepatocellular carcinoma except after successful curative intervention (3 months after resection or successful loco-regional therapy).
* Child score of 8 or less.
* Total serum bilirubin of 5 mg/dL or less.
* Platelet count of 30000/mm3 or more.
* Hemoglobin level of 10 g/DL or more.

Primary outcomes:
measure: fasting serum insulin
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References: