Type2 DiabetesQuid-NashNCT03634098
Identification and Validation of Noninvasive Biomarkers of the Diagnosis and Severity of NASH in Type 2 Diabetics
A study testing new quantitative imaging techniques with contast products, blood sample and second generation tests in people with Type2 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Metabolic diseases of the liver are silent affections whose morbidity is important. About 70% of patients with type 2 diabetes (T2D) are concerned. Of these, 50% develop clinically significant lesions (including non-alcoholic steatohepatitis or NASH) as they are associated with an increased risk of complications; and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- new quantitative imaging techniques with contast products, blood sample and second generation tests
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 970 participants
- Where
- 1 siteFrance
- Study dates
- 25 Oct 2018to 30 Sep 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Pilot phase : Volunteers (for reproducibility study) Inclusion criteria
- Voluntary
- Person aged 18 or over
Criteria for non-inclusion
- Refusal or inability to sign consent
- Vulnerable person according to article L1121-6 of the CSP
- Protected person of age
Clinical Study of Clinically Significant NASH or NASH Markers Performance with Standard NASH Criteria (patient with liver biopsy) Inclusion criteria
- Participant aged 18 or over
- Diabetic type 2 (ADA / WHO criteria mentioned in section 20.5)
- Liver biopsy planned in day hospital (HDJ) as part of routine care (indication of biopsy: or ALT> 30 IU for men or> 20 IU for women less than 1 month old) and/or steatosis on ultrasound )
- Hemoglobin> 7g / dL (or> 10 g / dL in case of cardiovascular or respiratory pathology)
Criteria for non-inclusion
- Refusal or inability to sign consent
- Vulnerable person: person deprived of liberty by a judicial or administrative decision, or subject to psychiatric care, and person admitted to a health or social institution for purposes other than that of research
- Protected person of age
- No affiliation or non-beneficiary of a social security scheme
- Pregnant or lactating woman
- Contraindication to MRI according to the French Society of Radiology (mentioned in section 20.4)
- Corpulence incompatible with the realization of an MRI
- Disease related to other etiologies
- Alcoholic liver disease
- Current infection of hepatitis B virus
- Current infection of hepatitis C virus
- Autoimmune hepatitis according to AASLD and EASL oTransferrin saturation>50%
- Alpha-1 antitrypsin deficiency ZZ or SZ
- Wilson's disease
- Obstruction of the blood vessels or bile ducts on ultrasound (on routine ultrasound If nothing is mentioned on the report, it is considered that there is no obstruction of the vessels blood or bile ducts)
- Liver transplant
Subgroup with Primovist:
-Contraindication to gadoxetic acid: Hypersensitivity to gadoxetic acid or to one of the excipients depending on the composition. Severe renal faillure (GFR <30 mL / min / 1.73 m²).
Subgroup with Sonovue:
-Any contraindication to Sonovue®, namely: hypersensitivity to sulfur hexafluoride or to one of the excipients of the specialty, right-left shunt, severe pulmonary arterial hypertension (> 90 mmHg), uncontrolled systemic hypertension, respiratory distress syndrome in adults, combination with dobutamine
Clinical study of the performance of second-generation tests for the diagnosis of metabolic liver disease: border population Inclusion criteria
- Consecutive patients aged 18 years or over
- Diabetic Type 2 (ADA / WHO criteria mentioned in section 20.5)
Criteria for non-inclusion
- Refusal or inability to sign consent
- Vulnerable person: person deprived of liberty by a judicial or administrative decision, person under psychiatric care and person admitted to a health or social institution for purposes other than research
- Protected person of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification and Validation of Noninvasive Biomarkers (Virtual Biopsy) of the Diagnosis and Severity of NASH in Type 2 Diabetics: a Cross-sectional Study
Metabolic diseases of the liver are silent affections whose morbidity is important. About 70% of patients with type 2 diabetes (T2D) are concerned. Of these, 50% develop clinically significant lesions (including non-alcoholic steatohepatitis or NASH) as they are associated with an increased risk of complications; and 15% progress to severe fibrosis or cirrhosis. These diseases are slowly progressive and asymptomatic. Their pathophysiology is poorly known. Management is hampered by the absence of a specific diagnostic marker, the need for invasive diagnostic procedures (liver biopsy), and the lack of established treatment.
QUID-NASH aims to develop a virtual liver biopsy in T2D participants, based on the identification of single or combined, multimodal, non-invasive biomarkers obtained by new quantitative imaging techniques (magnetic resonance and ultrafast ultrasound UFUS); and /or extensive clinical-biological phenotyping data; and/or data obtained by different omic approaches (metabolomics, targeted genetics, transcriptomics). Extracellular vesicle and immune cell profiling will complement these phenotyping data. This approach will also enable us to improve our understanding of pathophysiology (new signaling pathways, new therapeutic targets).
Read the detailed description
Metabolic diseases of the liver are silent affections whose morbidity is important. About 70% of patients with type 2 diabetes (T2D) are concerned. Of these, 50% develop clinically significant lesions (including non-alcoholic steatohepatitis or NASH) as they are associated with an increased risk of complications; and 15% progress to severe fibrosis or cirrhosis. These diseases are slowly progressive and asymptomatic. Their pathophysiology is poorly known. Management is hampered by the absence of a specific diagnostic marker, the need for invasive diagnostic procedures (liver biopsy), and the lack of established treatment. Non-invasive methods ("first-generation" tests) have recently seen significant growth: commercialization of FibroTest as a marker of fibrosis; FibroTest, Fibrometer and FibroScan, for the initial assessment of adult chronic hepatitis C; FibroTest, Fibrometer, and Enhanced Liver Fibrosis test (ELF-test) for diagnosis of metabolic liver disease and diagnosis of fibrosis; SteatoTest (APHP patent) for the diagnosis of steatosis. The ActiTest (APHP patent) is widely used in evaluating the necrotic-inflammatory activity of chronic viral hepatitis C and B. For the diagnosis of NASH alone the ActiTest is validated. The NashTest (APHP patent) is little used. Several biomarkers of imaging (liver ultrasound, FibroScan Controller Attenuated Parameter (CAP), elastography and nuclear magnetic resonance) are widely used for the diagnosis of steatosis. Two new "second generation" blood tests (APHP patents) are under development, Non Invasive Test-NASHr (NIT-NASHr), and NIT-A2F2. NIT-NASHr is a new combination of the components of SteatoTest and NASH-Test to assess the severity of NASH. NIT-A2F2 is a combination of NIT-NASHr and FibroTest for the diagnosis of clinically significant liver metabolic disease. These tests will be the subject in the project of a validation of their performances in the context of use (T2D without other liver disease). At the same time, significant progress has been made in integrating omic data to characterize various pathologies and to identify their mechanisms. The transcriptomics and metabolomics of body fluids are particularly promising for the construction of "third generation" tests.
QUID-NASH aims to develop a virtual liver biopsy in T2D participants, based on the identification of single or combined, multimodal, non-invasive biomarkers obtained by new quantitative imaging techniques (magnetic resonance and ultrafast ultrasound UFUS); and / or extensive clinical-biological phenotyping data; and / or data obtained by different omic approaches (metabolomics, targeted genetics, transcriptomics). Extracellular vesicle and immune cell profiling will complement this data. This approach will also enable us to improve knowledge of the pathology (new signaling pathways, new therapeutic targets).
- Conditions
- Type2 Diabetes
- Being tested
- new quantitative imaging techniques with contast products, blood sample, second generation tests
- Keywords
- Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new quantitative imaging techniques with contast productsDevice
magnetic resonance +/- Primovist and ultrafast ultrasound UFUS +Sonovue
blood sampleDiagnostic test
extensive clinical-biological phenotyping data; and / or data obtained by different omic approaches (metabolomics, targeted genetics, transcriptomics). Extracellular vesicle and immune cell profiling will complement this data
second generation testsDiagnostic test
second generation tests NIT-NASHr et NIT-A2F2
| Study group | Role | What they receive |
|---|---|---|
| Volunteers | Experimental | Exams performed on volunteers with other purpose than liver disease or diabetes in two centers:
* MRI
* Ultrasound AixPlorer These examinations are carried out in 2 differents centers at 1month intervals Receives: Device: new quantitative imaging techniques with contast products |
| T2D liver test abnormalities's participants | Experimental | Exams performed on type 2 diabetic patients with liver test abnormalities :
* sample for analysis and biocollection
* MRI +/-Primovist
* Ultrasound AixPlorer +Sonovue Receives: Device: new quantitative imaging techniques with contast products; Diagnostic Test: blood sample; Diagnostic Test: second generation tests |
| T2D participants without liver test abnormality | No intervention | type 2 diabetic participants without liver test abnormality and not undergoing liver biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study in type 2 diabetic participants with liver biopsy, the performance of a composite biomarker (3rd generation test) for the diagnosis of NASH
Histological diagnosis of NASH (as established by centralized re-reading of liver biopsy slides), blinded to omic results and imaging.
Measured: 1 month
Secondary outcomes (11)
To study in type 2 diabetic participants with or without liver biopsy, performance of a composite biomarker for the diagnosis of clinically significant metabolic liver diseases
diagnosis of clinically significant liver metabolic disease (SAF-Score ≥A2 or ≥F2) adjudicated by an independent committee
Measured: 1 month
To study in type 2 diabetic participants with liver biopsy, the performance of a single or composite biomarker for the diagnosis of NASH elemental lesions
histological diagnosis of elementary lesions of NASH (lobular inflammation, ballooning, steatosis)
Measured: 1 month
To study inter-center and intra-participants reproducibility of imaging measurements. a graphical evaluation will be conducted using a representation of Bland-Altman.
By MRI: steatosis, biomechanical properties, T1, diffusivity
Measured: 1 month
To study inter-center and intra-participants reproducibility of imaging measurements.a graphical evaluation will be conducted using a representation of Bland-Altman.
By AixPlorer ultrasound: steatosis, biomechanical properties, vascular properties
Measured: 1 month
To study in type 2 diabetic participants the performance of second-generation tests for the diagnosis of metabolic liver diseases
metabolic liver disease (adjudicated by an independent committee)
Measured: 1 day
Constitution of a bio-collection
stool
Measured: 1 month
Constitution of a bio-collection
urine
Measured: 1 month
Constitution of a bio-collection
plasma
Measured: 1 month
Constitution of a bio-collection
serum
Measured: 1 month
Constitution of a bio-collection
mononuclear cells of peripheral blood
Measured: 1 month
Constitution of a bio-collection
Liver tissue
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start25 Oct 2018
- Primary completion31 Jul 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 970 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Castera, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634098
- Sponsor's protocol ID
- P171105j
- Other IDs
- 2018-A00311-54
- Acronym
- Quid-Nash
- Status last verified
- Mar 2022
- First submitted
- 16 Jul 2018
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Castera L, Garteiser P, Laouenan C, Vidal-Trecan T, Vallet-Pichard A, Manchon P, Paradis V, Czernichow S, Roulot D, Larger E, Pol S, Bedossa P, Correas JM, Valla D, Gautier JF, Van Beers BE; QUID NASH investigators. Prospective head-to-head comparison of non-invasive scores for diagnosis of fibrotic MASH in patients with type 2 diabetes. J Hepatol. 2024 Aug;81(2):195-206. doi: 10.1016/j.jhep.2024.03.023. Epub 2024 Mar 27.
PubMed 38548067Poynard T, Deckmyn O, Peta V, Paradis V, Gautier JF, Brzustowski A, Bedossa P, Castera L, Pol S, Valla D; Quid-Nash Consortium. Prospective direct comparison of non-invasive liver tests in outpatients with type 2 diabetes using intention-to-diagnose analysis. Aliment Pharmacol Ther. 2023 Nov;58(9):888-902. doi: 10.1111/apt.17688. Epub 2023 Aug 29.
PubMed 37642160Poynard T, Paradis V, Mullaert J, Deckmyn O, Gault N, Marcault E, Manchon P, Si Mohammed N, Parfait B, Ibberson M, Gautier JF, Boitard C, Czernichow S, Larger E, Drane F, Castille JM, Peta V, Brzustowski A, Terris B, Vallet-Pichard A, Roulot D, Laouenan C, Bedossa P, Castera L, Pol S, Valla D; Quid-Nash consortium. Prospective external validation of a new non-invasive test for the diagnosis of non-alcoholic steatohepatitis in patients with type 2 diabetes. Aliment Pharmacol Ther. 2021 Oct;54(7):952-966. doi: 10.1111/apt.16543. Epub 2021 Aug 16.
PubMed 34398492
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Validation of Noninvasive Biomarkers (Virtual Biopsy) of the Diagnosis and Severity of NASH in Type 2 Diabetics: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03634098
- Acronym / sponsor ID
- Quid-Nash / P171105j
- Conditions
- Type2 Diabetes
- Keywords
- Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 970 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 16 Aug 2018 (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.
Metabolic diseases of the liver are silent affections whose morbidity is important. About 70% of patients with type 2 diabetes (T2D) are concerned. Of these, 50% develop clinically significant lesions (including non-alcoholic steatohepatitis or NASH) as they are associated with an increased risk of complications; and 15% progress to severe fibrosis or cirrhosis. These diseases are slowly progressive and asymptomatic. Their pathophysiology is poorly known. Management is hampered by the absence of a specific diagnostic marker, the need for invasive diagnostic procedures (liver biopsy), and the lack of established treatment.
QUID-NASH aims to develop a virtual liver biopsy in T2D participants, based on the identification of single or combined, multimodal, non-invasive biomarkers obtained by new quantitative imaging techniques (magnetic resonance and ultrafast ultrasound UFUS); and /or extensive clinical-biological phenotyping data; and/or data obtained by different omic approaches (metabolomics, targeted genetics, transcriptomics). Extracellular vesicle and immune cell profiling will complement these phenotyping data. This approach will also enable us to improve our understanding of pathophysiology (new signaling pathways, new therapeutic targets).
Detailed description
Metabolic diseases of the liver are silent affections whose morbidity is important. About 70% of patients with type 2 diabetes (T2D) are concerned. Of these, 50% develop clinically significant lesions (including non-alcoholic steatohepatitis or NASH) as they are associated with an increased risk of complications; and 15% progress to severe fibrosis or cirrhosis. These diseases are slowly progressive and asymptomatic. Their pathophysiology is poorly known. Management is hampered by the absence of a specific diagnostic marker, the need for invasive diagnostic procedures (liver biopsy), and the lack of established treatment. Non-invasive methods ("first-generation" tests) have recently seen significant growth: commercialization of FibroTest as a marker of fibrosis; FibroTest, Fibrometer and FibroScan, for the initial assessment of adult chronic hepatitis C; FibroTest, Fibrometer, and Enhanced Liver Fibrosis test (ELF-test) for diagnosis of metabolic liver disease and diagnosis of fibrosis; SteatoTest (APHP patent) for the diagnosis of steatosis. The ActiTest (APHP patent) is widely used in evaluating the necrotic-inflammatory activity of chronic viral hepatitis C and B. For the diagnosis of NASH alone the ActiTest is validated. The NashTest (APHP patent) is little used. Several biomarkers of imaging (liver ultrasound, FibroScan Controller Attenuated Parameter (CAP), elastography and nuclear magnetic resonance) are widely used for the diagnosis of steatosis. Two new "second generation" blood tests (APHP patents) are under development, Non Invasive Test-NASHr (NIT-NASHr), and NIT-A2F2. NIT-NASHr is a new combination of the components of SteatoTest and NASH-Test to assess the severity of NASH. NIT-A2F2 is a combination of NIT-NASHr and FibroTest for the diagnosis of clinically significant liver metabolic disease. These tests will be the subject in the project of a validation of their performances in the context of use (T2D without other liver disease). At the same time, significant progress has been made in integrating omic data to characterize various pathologies and to identify their mechanisms. The transcriptomics and metabolomics of body fluids are particularly promising for the construction of "third generation" tests.
QUID-NASH aims to develop a virtual liver biopsy in T2D participants, based on the identification of single or combined, multimodal, non-invasive biomarkers obtained by new quantitative imaging techniques (magnetic resonance and ultrafast ultrasound UFUS); and / or extensive clinical-biological phenotyping data; and / or data obtained by different omic approaches (metabolomics, targeted genetics, transcriptomics). Extracellular vesicle and immune cell profiling will complement this data. This approach will also enable us to improve knowledge of the pathology (new signaling pathways, new therapeutic targets).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Volunteers | Experimental | Device: new quantitative imaging techniques with contast productsExams performed on volunteers with other purpose than liver disease or diabetes in two centers: * MRI * Ultrasound AixPlorer These examinations are carried out in 2 differents centers at 1month intervals |
| T2D liver test abnormalities's participants | Experimental | Device: new quantitative imaging techniques with contast products, Diagnostic Test: blood sample, Diagnostic Test: second generation testsExams performed on type 2 diabetic patients with liver test abnormalities : * sample for analysis and biocollection * MRI +/-Primovist * Ultrasound AixPlorer +Sonovue |
| T2D participants without liver test abnormality | No intervention | –type 2 diabetic participants without liver test abnormality and not undergoing liver biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| new quantitative imaging techniques with contast productsmagnetic resonance +/- Primovist and ultrafast ultrasound UFUS +Sonovue | Device | T2D liver test abnormalities's participants, Volunteers |
| blood sampleextensive clinical-biological phenotyping data; and / or data obtained by different omic approaches (metabolomics, targeted genetics, transcriptomics). Extracellular vesicle and immune cell profiling will complement this data | Diagnostic test | T2D liver test abnormalities's participants |
| second generation testssecond generation tests NIT-NASHr et NIT-A2F2 | Diagnostic test | T2D liver test abnormalities's participants |
Primary outcome
To study in type 2 diabetic participants with liver biopsy, the performance of a composite biomarker (3rd generation test) for the diagnosis of NASH
Time frame: 1 month
Histological diagnosis of NASH (as established by centralized re-reading of liver biopsy slides), blinded to omic results and imaging.
11 secondary outcomes
To study in type 2 diabetic participants with or without liver biopsy, performance of a composite biomarker for the diagnosis of clinically significant metabolic liver diseases
Time frame: 1 month
To study in type 2 diabetic participants with liver biopsy, the performance of a single or composite biomarker for the diagnosis of NASH elemental lesions
Time frame: 1 month
To study inter-center and intra-participants reproducibility of imaging measurements. a graphical evaluation will be conducted using a representation of Bland-Altman.
Time frame: 1 month
To study inter-center and intra-participants reproducibility of imaging measurements.a graphical evaluation will be conducted using a representation of Bland-Altman.
Time frame: 1 month
To study in type 2 diabetic participants the performance of second-generation tests for the diagnosis of metabolic liver diseases
Time frame: 1 day
Constitution of a bio-collection
Time frame: 1 month
Constitution of a bio-collection
Time frame: 1 month
Constitution of a bio-collection
Time frame: 1 month
Constitution of a bio-collection
Time frame: 1 month
Constitution of a bio-collection
Time frame: 1 month
Constitution of a bio-collection
Time frame: 1 month
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 8 Dec 2022.
- Derived from this study: PubMed 38548067Castera L, Garteiser P, Laouenan C, Vidal-Trecan T, Vallet-Pichard A, Manchon P, Paradis V, Czernichow S, Roulot D, Larger E, Pol S, Bedossa P, Correas JM, Valla D, Gautier JF, Van Beers BE; QUID NASH investigators. Prospective head-to-head comparison of non-invasive scores for diagnosis of fibrotic MASH in patients with type 2 diabetes. J Hepatol. 2024 Aug;81(2):195-206. doi: 10.1016/j.jhep.2024.03.023. Epub 2024 Mar 27.
- Derived from this study: PubMed 37642160Poynard T, Deckmyn O, Peta V, Paradis V, Gautier JF, Brzustowski A, Bedossa P, Castera L, Pol S, Valla D; Quid-Nash Consortium. Prospective direct comparison of non-invasive liver tests in outpatients with type 2 diabetes using intention-to-diagnose analysis. Aliment Pharmacol Ther. 2023 Nov;58(9):888-902. doi: 10.1111/apt.17688. Epub 2023 Aug 29.
- Derived from this study: PubMed 34398492Poynard T, Paradis V, Mullaert J, Deckmyn O, Gault N, Marcault E, Manchon P, Si Mohammed N, Parfait B, Ibberson M, Gautier JF, Boitard C, Czernichow S, Larger E, Drane F, Castille JM, Peta V, Brzustowski A, Terris B, Vallet-Pichard A, Roulot D, Laouenan C, Bedossa P, Castera L, Pol S, Valla D; Quid-Nash consortium. Prospective external validation of a new non-invasive test for the diagnosis of non-alcoholic steatohepatitis in patients with type 2 diabetes. Aliment Pharmacol Ther. 2021 Oct;54(7):952-966. doi: 10.1111/apt.16543. Epub 2021 Aug 16.
- Individual participant dataSharing planned: Undecided
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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.
Laurent Castera principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing new quantitative imaging techniques with contast products, blood sample and second generation tests in people with Type2 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 8 Dec 2022. 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 France. 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?
To study in type 2 diabetic participants with liver biopsy, the performance of a composite biomarker (3rd generation test) for the diagnosis of NASH (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03634098, which also lists 3 linked publications.
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 8 Dec 2022.