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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03908294
• Other study ID #: JWGUHMED1-012
• Status: Completed
• Start date: August 13, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: July 2020
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Glucose Metabolism Disorders
• Hepatitis
• Hepatitis A
• Hepatitis C
• Liver Cirrhosis
• Liver Fibrosis
• Metabolic Diseases

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Germany	Klinikum der J. W. Goethe-Universität	Frankfurt am Main

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients with changes in glucose metabolism measured by fasting glucose	rate of patients with normal fasting glucose (<100mg/dl), prediabetes (glucose 100-125mg/d) and diabetes (>126mg/dl)	From baseline up to one year after end of treatment
Primary	Rate of patients with changes in glucose metabolism measured by Homeostasis Model Assessment-index (HOMA)	Homeostasis Model Assessment-index (HOMA) measures insulin resistance: <2,0 insulin resistance unlikely; 2,0 - 2,5 insulin resistance possible; 2,5 - 5,0 insulin resitance likely; >5,0 proven insulin resitance	From baseline up to one year after end of treatment
Primary	Rate of patients with changes in glucose metabolism measured by HbA1c	rate of patients with normal HbA1c (>6% Hb), prediabetes (6-6.4% Hb) and diabetes (>6.5% Hb)	From baseline up to one year after end of treatment
Secondary	Liver fibrosis 1	Evaluation of changes of parameters reflecting liver fibrosis: Fibroscan	From baseline up to one year after end of treatment
Secondary	Liver fibrosis 2	Evaluation of changes of parameters reflecting liver fibrosis: ARFI	From baseline up to one year after end of treatment