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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Rate of patients with changes in glucose metabolism measured by fasting glucose
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with chronic hepatitis C infection and planned antiviral therapy with direct-acting antiviral agents
- •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
Outcomes
Primary Outcomes
Rate of patients with changes in glucose metabolism measured by fasting glucose
Time Frame: 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 HbA1c
Time Frame: 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)
Rate of patients with changes in glucose metabolism measured by Homeostasis Model Assessment-index (HOMA)
Time Frame: 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
Secondary Outcomes
- Liver fibrosis 2(From baseline up to one year after end of treatment)
- Liver fibrosis 1(From baseline up to one year after end of treatment)
Investigators
Georg Dultz
Prof.
Johann Wolfgang Goethe University Hospital