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Completed

NCT Number: NCT03908294

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

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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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with chronic hepatitis C infection and planned antiviral therapy with direct-acting antiviral agents
  • Age 18-99
  • Informed Consent

Exclusion criteria

  • Patients without legal capacity for informed consent
  • alcohol intake ≥ 20 g/d (f) und 30 g/d (m) within one year of study screening
  • Decompensated cirrhosis
  • viral co-infection
  • HIV infection
  • Non-viral chronic liver disease
  • Malignancy within 5 years before study screening except basalioma
  • liver transplant recipients
  • weight loss ≥10% within 3 months before study screening
  • Changes of diabetic drug treatment, lipid lowering therapy oder vitamin E within three months before study screening.
  • Intake of medication associated with hepatic steatosis (e.g. steroids, methotrexate, amiodarone, tamoxifen, valproat, flutamide, tetracyclins, cytostatics etc.)
  • Bariatric surgery in personal history
  • Clinically relevant congestive heart disease, cardiac arrythmia, valvular heart disease)
  • Implanted cardiac pacemaker or defibrillator
  • Patients during pregnancy or lactation

Treatment and study plan

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

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.

Primary outcomes

  1. 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)

  2. 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:

    • <2,0 insulin resistance unlikely
    • 2,0 - 2,5 insulin resistance possible
    • 2,5 - 5,0 insulin resitance likely
    • >5,0 proven insulin resitance
  3. 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)

Secondary outcomes

  1. Liver fibrosis 1

    Time frame: From baseline up to one year after end of treatment

    Evaluation of changes of parameters reflecting liver fibrosis: Fibroscan

  2. Liver fibrosis 2

    Time frame: From baseline up to one year after end of treatment

    Evaluation of changes of parameters reflecting liver fibrosis: ARFI

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 9, 2019
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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