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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-13

Study Completion Date

2020-04-01

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.

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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.

Conditions

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Liver Fibrosis Hepatitis C Glucose Metabolism Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Lab tests, non-invasive fibrosis (Fibroscan/ARFI)

Intervention Type 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.

Interventions

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Lab 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No