Hepatitis C Clinical Trial
Official title:
Insulin Resistance and Resistin In Non-Diabetic Patients With Chronic Hepatitis C Before and After Direct-Acting Antiviral Drugs.
Verified date | June 2020 |
Source | Alexandria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Medicine | Alexandria |
Lead Sponsor | Collaborator |
---|---|
Alexandria University |
Egypt,
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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