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

July 20, 2020 updated by: Georg Dultz, Johann Wolfgang Goethe University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt am Main, Germany
        • Klinikum der J. W. Goethe-Universität

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with chronic hepatitis C infection with planned antiviral DAA treatment

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From baseline up to one year after end of treatment
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
From baseline up to one year after end of treatment
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)
From baseline up to one year after end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver fibrosis 1
Time Frame: From baseline up to one year after end of treatment
Evaluation of changes of parameters reflecting liver fibrosis: Fibroscan
From baseline up to one year after end of treatment
Liver fibrosis 2
Time Frame: From baseline up to one year after end of treatment
Evaluation of changes of parameters reflecting liver fibrosis: ARFI
From baseline up to one year after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Investigators

  • Principal Investigator: Tania Welzel, MD, Prof.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2018

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

April 2, 2019

First Submitted That Met QC Criteria

April 5, 2019

First Posted (Actual)

April 9, 2019

Study Record Updates

Last Update Posted (Actual)

July 21, 2020

Last Update Submitted That Met QC Criteria

July 20, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JWGUHMED1-012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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