Glucose Metabolism DisordersNCT03908294
Change of Glucose Metabolism and Fibrosis Markers in Patients With Hepatitis C Under Treatment With Antiviral Agents
An observational study of Glucose Metabolism Disorders and Liver Fibrosis, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Glucose Metabolism Disorders, Liver Fibrosis, Hepatitis C
- What is being tested?
- Lab tests, non-invasive fibrosis (Fibroscan/ARFI)
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- 13 Aug 2018to 1 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
Study population: Patients with chronic hepatitis C infection with planned antiviral DAA treatment
Who may be able to join
- Patients with chronic hepatitis C infection and planned antiviral therapy with direct-acting antiviral agents
- Age 18-99
- Informed Consent
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Glucose Metabolism Disorders, Liver Fibrosis, Hepatitis C
- Being tested
- Lab tests, non-invasive fibrosis (Fibroscan/ARFI)
- Medical subject headings
- Glucose Metabolism Disorders, Liver Cirrhosis, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Lab tests, non-invasive fibrosis (Fibroscan/ARFI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
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
Measured: From baseline up to one year after end of treatment
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)
Measured: From baseline up to one year after end of treatment
Secondary outcomes (2)
Liver fibrosis 1
Evaluation of changes of parameters reflecting liver fibrosis: Fibroscan
Measured: From baseline up to one year after end of treatment
Liver fibrosis 2
Evaluation of changes of parameters reflecting liver fibrosis: ARFI
Measured: From baseline up to one year after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start13 Aug 2018
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Metabolism DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georg Dultz, Johann Wolfgang Goethe University Hospital
- Investigators
- Tania Welzel, MD, Principal investigator, Prof.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908294
- Sponsor's protocol ID
- JWGUHMED1-012
- Status last verified
- Jul 2020
- First submitted
- 2 Apr 2019
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03908294
- Acronym / sponsor ID
- JWGUHMED1-012
- Conditions
- Glucose Metabolism Disorders, Liver Fibrosis, Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic hepatitis C under antiviral treatment with DAA | – | Diagnostic Test: 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic hepatitis C infection with planned antiviral DAA treatment
Key inclusion criteria (3 listed)
- Patients with chronic hepatitis C infection and planned antiviral therapy with direct-acting antiviral agents
- Age 18-99
- Informed Consent
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Chronic hepatitis C under antiviral treatment with DAA |
Primary outcome
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)
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
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)
2 secondary outcomes
Liver fibrosis 1
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tania Welzel, MD principal investigator
Prof.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glucose Metabolism Disorders and Liver Fibrosis, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with changes in glucose metabolism measured by fasting glucose (time frame: From baseline up to one year after end of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.