Glucose Metabolism Disorders, Hepatitis C, Liver Fibrosis
Conditions
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTLab tests, non-invasive fibrosis (Fibroscan/ARFI)
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.
Sponsors
Johann Wolfgang Goethe University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Inclusion criteria
1. Patients with chronic hepatitis C infection and planned antiviral therapy with direct-acting antiviral agents 2. Age 18-99 3. Informed Consent
Exclusion criteria
1. Patients without legal capacity for informed consent 2. alcohol intake ≥ 20 g/d (f) und 30 g/d (m) within one year of study screening 3. Decompensated cirrhosis 4. viral co-infection 5. HIV infection 6. Non-viral chronic liver disease 7. Malignancy within 5 years before study screening except basalioma 8. liver transplant recipients 9. weight loss ≥10% within 3 months before study screening 10. Changes of diabetic drug treatment, lipid lowering therapy oder vitamin E within three months before study screening. 11. Intake of medication associated with hepatic steatosis (e.g. steroids, methotrexate, amiodarone, tamoxifen, valproat, flutamide, tetracyclins, cytostatics etc.) 12. Bariatric surgery in personal history 13. Clinically relevant congestive heart disease, cardiac arrythmia, valvular heart disease) 14. Implanted cardiac pacemaker or defibrillator 15. Patients during pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients with changes in glucose metabolism measured by fasting glucose | From baseline up to one year after end of treatment | rate of patients with normal fasting glucose (\<100mg/dl), prediabetes (glucose 100-125mg/d) and diabetes (\>126mg/dl) |
| Rate of patients with changes in glucose metabolism measured by Homeostasis Model Assessment-index (HOMA) | From baseline up to one year after end of treatment | Homeostasis Model Assessment-index (HOMA) measures insulin resistance: 1. \<2,0 insulin resistance unlikely 2. 2,0 - 2,5 insulin resistance possible 3. 2,5 - 5,0 insulin resitance likely 4. \>5,0 proven insulin resitance |
| Rate of patients with changes in glucose metabolism measured by HbA1c | From baseline up to one year after end of treatment | rate of patients with normal HbA1c (\>6% Hb), prediabetes (6-6.4% Hb) and diabetes (\>6.5% Hb) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Liver fibrosis 1 | From baseline up to one year after end of treatment | Evaluation of changes of parameters reflecting liver fibrosis: Fibroscan |
| Liver fibrosis 2 | From baseline up to one year after end of treatment | Evaluation of changes of parameters reflecting liver fibrosis: ARFI |
Countries
Germany
Outcome results
None listed