Clinical trial NCT03908294: Change of Glucose Metabolism and Fibrosis Markers in Patients With Hepatitis C Under Treatment With Antiviral Agents
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glucose Metabolism Disorders
Liver Fibrosis
Hepatitis C
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic hepatitis C infection with planned antiviral DAA treatment

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of patients with changes in glucose metabolism measured by fasting glucose
timeFrame: From baseline up to one year after end of treatment
measure: Rate of patients with changes in glucose metabolism measured by Homeostasis Model Assessment-index (HOMA)
timeFrame: From baseline up to one year after end of treatment
measure: Rate of patients with changes in glucose metabolism measured by HbA1c
timeFrame: From baseline up to one year after end of treatment
Secondary outcomes:
measure: Liver fibrosis 1
timeFrame: From baseline up to one year after end of treatment
measure: Liver fibrosis 2
timeFrame: From baseline up to one year after end of treatment
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Klinikum der J. W. Goethe-Universität
Study officials:
affiliation: Prof.
name: Tania Welzel, MD
role: PRINCIPAL_INVESTIGATOR
References: