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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic hepatitis C under antiviral treatment with DAA | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lab tests, non-invasive fibrosis (Fibroscan/ARFI) | Diagnostic Test | 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. |
| 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:
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic hepatitis C infection with planned antiviral DAA treatment
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| Name | Affiliation | Role |
|---|---|---|
| Tania Welzel, MD | Prof. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum der J. W. Goethe-Universität | Frankfurt am Main | Germany |
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| From baseline up to one year after end of treatment |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008103 | Liver Cirrhosis |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
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