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

Completed

• Conditions: Hepatitis C; Liver Fibrosis; Glucose Metabolism Disorders
• Interventions: Diagnostic Test: Lab tests, non-invasive fibrosis (Fibroscan/ARFI)

• Registration Number: NCT03908294
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

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 Timeline

• Study Start: 2018-08-13
• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-05
• Study First Posted: 2019-04-09
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-20
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic hepatitis C under antiviral treatment with DAA	Lab tests, non-invasive fibrosis (Fibroscan/ARFI)	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.

Primary Outcome Measures

Name	Time	Method
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 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)
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

Secondary Outcome Measures

Name	Time	Method
Liver fibrosis 2	From baseline up to one year after end of treatment	Evaluation of changes of parameters reflecting liver fibrosis: ARFI
Liver fibrosis 1	From baseline up to one year after end of treatment	Evaluation of changes of parameters reflecting liver fibrosis: Fibroscan

Trial Locations

Locations (1)

Klinikum der J. W. Goethe-Universität; 🇩🇪 Frankfurt am Main, Germany