Non-alcoholic Fatty Liver Disease (NAFLD)NCT01997424
Association of Non-alcoholic Fatty Liver Disease and Diabetes Mellitus
A study testing FibroScan, Echosens, Paris, France in people with Non-alcoholic Fatty Liver Disease (NAFLD), run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
This study will evaluate the association of non-alcoholic fatty liver disease and diabetes mellitus. Patients presenting in our clinic with Diabetes mellitus type 1 or 2 will receive the following examination: Transient Elastography and Controlled Attenuation Parameter using the FibroScan blood examination including… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease (NAFLD)
- What is being tested?
- FibroScan, Echosens, Paris, France
- Type of treatment
- Medical device
- How many people
- 340 participants
- Where
- 1 siteGermany
- Study dates
- May 2013to 31 Dec 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 years and older
- Written informed consent
- Diabetes mellitus type 1 or 2
Who cannot join
- Patients with mental diseases
- Pregnancy or lactation
- Ascites
- Continued alcohol consumption (> 21 drinks/week for male and > 14 drinks/week for female patients)
- Chronic liver disease (viral hepatitis, autoimmune hepatitis, PBC, PSC, hemochromatosis, M Wilson)
- Hepatocellular carcinoma/ Liver metastasis
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the association of non-alcoholic fatty liver disease and diabetes mellitus. Patients presenting in our clinic with Diabetes mellitus type 1 or 2 will receive the following examination:
- Transient Elastography and Controlled Attenuation Parameter using the FibroScan
- blood examination including biochemical markers The statistically calculated sample size needed is 340 patients.
- Being tested
- Controlled Attenuation Parameter (CAP), Echosens, Paris, France, FibroScan, Echosens, Paris, France
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled Attenuation Parameter (CAP), Echosens, Paris, FranceDevice
FibroScan, Echosens, Paris, FranceDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Steatosis
- Evaluating the presence of liver steatosis in patients with diabetes mellitus using the ultrasound-based method "Controlled Attenuation Parameter", which is integrated in the FibroScan machine and can non-invasively quantify liver steatosis (Steatosis fibrosis scores I-III [ Designated as safety issue: No ]; Steatosis scores: 0 = <5% I = 5-33% II = 33-66% III = >66%)
Measured: one day
Secondary outcomes (2)
Fibrosis
- Evaluation of the prevalence of liver fibrosis using transientelastography (FibroScan) and serological markers in patients with diabetes mellitus (Liver fibrosis scores I-IV (METAVIR) [ Designated as safety issue: No ]; METAVIR fibrosis scores: I = mild fibrosis II = significant fibrosis III = advanced fibrosis IV = cirrhosis)
Measured: one day
Steatosis (serum)
- Evaluating the prevalence of liver steatosis using serum steatosis markers in patients with diabetes mellitus
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startMay 2013
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver Disease (NAFLD)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 340 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
- Mireen Friedrich-Rust, MD, Principal investigator, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997424
- Sponsor's protocol ID
- JWGUHMED1-007
- Status last verified
- Feb 2021
- First submitted
- 23 Oct 2013
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Non-alcoholic Fatty Liver Disease and Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01997424
- Acronym / sponsor ID
- JWGUHMED1-007
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 28 Nov 2013 (estimated)
- 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.
This study will evaluate the association of non-alcoholic fatty liver disease and diabetes mellitus. Patients presenting in our clinic with Diabetes mellitus type 1 or 2 will receive the following examination:
- Transient Elastography and Controlled Attenuation Parameter using the FibroScan
- blood examination including biochemical markers The statistically calculated sample size needed is 340 patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, 18 years and older
- Written informed consent
- Diabetes mellitus type 1 or 2
Key exclusion criteria (6 listed)
- Patients with mental diseases
- Pregnancy or lactation
- Ascites
- Continued alcohol consumption (> 21 drinks/week for male and > 14 drinks/week for female patients)
- Chronic liver disease (viral hepatitis, autoimmune hepatitis, PBC, PSC, hemochromatosis, M Wilson)
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 |
|---|---|---|
| Controlled Attenuation Parameter (CAP), Echosens, Paris, France | Device | – |
| FibroScan, Echosens, Paris, France | Device | – |
Primary outcome
Steatosis
Time frame: one day
• Evaluating the presence of liver steatosis in patients with diabetes mellitus using the ultrasound-based method "Controlled Attenuation Parameter", which is integrated in the FibroScan machine and can non-invasively quantify liver steatosis (Steatosis fibrosis scores I-III [ Designated as safety issue: No ]; Steatosis scores: 0 = <5% I = 5-33% II = 33-66% III = >66%)
2 secondary outcomes
Fibrosis
Time frame: one day
Steatosis (serum)
Time frame: one day
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 3 Feb 2021.
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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.
Mireen Friedrich-Rust, MD principal investigator
Goethe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FibroScan, Echosens, Paris, France in people with Non-alcoholic Fatty Liver Disease (NAFLD), 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 6 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 3 Feb 2021. 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?
Steatosis (time frame: one day). 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 3 Feb 2021.