Change of Glucose Metabolism and Fibrosis Markers in Patients With Hepatitis C Under Treatment With Antiviral Agents

Study Overview
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Brief Summary
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Chronic hepatitis C infection is associated with changes of glucose metabolism end increased frequency of impaired glucose tolerance. This might be a additional risk factor for disease and fibrosis progression. The study aims to evaluate whether a therapy with direct-acting antiviral agents leading to a sustained virologic response directly impacts parameters reflecting glucose metabolism and fibrosis.

Detailed Description
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Chronic hepatitis C infection is associated with changes of glucose metabolism end increased frequency of impaired glucose tolerance. It is well known that metabolic factors play an important role in fibrosis progression and steatohepatitis for example in non-alcoholic steatohepatitis (NASH). Accordingly changes in glucose metabolism in patients with chronic hepatitis C might directly impact disease and fibrosis progression. The study aims to evaluate whether a therapy with direct-acting antiviral agents leading to a sustained virologic response directly impacts parameters reflecting glucose metabolism and fibrosis. Follow-up examinations will determine the long-term metabolic changes of successful elimination of the virus by antiviral treatment.

Official Title
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Examination of Changes of Parameters of Glucose Metabolism and Liver Fibrosis Stadium by Acoustic Radiation Force Impulse-Imaging and Transient Elastography in Patients With Chronic Hepatitis C Under Antiviral Treatment

Conditions
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Hepatitis C, Glucose Metabolism Disorders, Liver Fibrosis

Intervention / Treatment
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* Diagnostic Test: Lab tests, non-invasive fibrosis (Fibroscan/ARFI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chronic hepatitis C infection and planned antiviral therapy with direct-acting antiviral agents Age 18-99 Informed Consent Exclusion Criteria: Patients without legal capacity for informed consent alcohol intake ≥ 20 g/d (f) und 30 g/d (m) within one year of study screening Decompensated cirrhosis viral co-infection HIV infection Non-viral chronic liver disease Malignancy within 5 years before study screening except basalioma liver transplant recipients weight loss ≥10% within 3 months before study screening Changes of diabetic drug treatment, lipid lowering therapy oder vitamin E within three months before study screening. Intake of medication associated with hepatic steatosis (e.g. steroids, methotrexate, amiodarone, tamoxifen, valproat, flutamide, tetracyclins, cytostatics etc.) Bariatric surgery in personal history Clinically relevant congestive heart disease, cardiac arrythmia, valvular heart disease) Implanted cardiac pacemaker or defibrillator Patients during pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic hepatitis C under antiviral treatment with DAA<br>Patients with chronic hepatitis C infection and planned DAA treatment are enrolled prospectively. Parameters of glucose metabolism and liver fibrosis are measured at baseline, during therapy and up to one year after end of treatment. | Diagnostic Test: Lab tests, non-invasive fibrosis (Fibroscan/ARFI)<br>* Patient characteristics, lab values reflecting glucose metabolism and non-invasive fibrosis tests are documented at baseline, during therapy and up to one year after end of treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with changes in glucose metabolism measured by fasting glucose | rate of patients with normal fasting glucose (<100mg/dl), prediabetes (glucose 100-125mg/d) and diabetes (>126mg/dl) | From baseline up to one year after end of treatment | 
| Rate of patients with changes in glucose metabolism measured by Homeostasis Model Assessment-index (HOMA) | Homeostasis Model Assessment-index (HOMA) measures insulin resistance: <2,0 insulin resistance unlikely 2,0 - 2,5 insulin resistance possible 2,5 - 5,0 insulin resitance likely >5,0 proven insulin resitance | From baseline up to one year after end of treatment | 
| Rate of patients with changes in glucose metabolism measured by HbA1c | rate of patients with normal HbA1c (>6% Hb), prediabetes (6-6.4% Hb) and diabetes (>6.5% Hb) | From baseline up to one year after end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver fibrosis 1 | Evaluation of changes of parameters reflecting liver fibrosis: Fibroscan | From baseline up to one year after end of treatment | 
| Liver fibrosis 2 | Evaluation of changes of parameters reflecting liver fibrosis: ARFI | From baseline up to one year after end of treatment |