NAFLDNAFLDIA1NCT04664036
Prevalence, Incidence and Characteristics of NAFLD/NASH in Type 1 Diabetes Mellitus
An observational study of NAFLD and Type 1 Diabetes, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
Nonalcoholic fatty liver disease (NAFLD) is a condition characterized by intrahepatic fat accumulation. It is closely related to insulin resistance. To date, it remains unclear whether NAFLD is common in patients with type 1 diabetes or if NAFLD translates into an increased health burden in this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NAFLD, Type 1 Diabetes, Cardiovascular Diseases
- What is being tested?
- ultrasound, elastography and FLI
- How many people
- 700 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Sep 2018to 30 Jul 2025
- How long will I take part?
- 5 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult type 1 diabetes patients followed in the outpatient diabetes clinic of the Antwerp University Hospital
Who may be able to join
- Type 1 diabetes
- Adult age
- Informed consent given
Who cannot join
- Secondary liver disease
- Excess alcohol usage
- Pregnancy
- Use of steatogenic medication
- Active cancer or oncological treatment
- History of organ transplantation
Trial locations and contacts
1 site in 1 country.
Rie Braspenning, nurse contact
Belgium1 site, 1 recruiting
- Recruiting
Antwerp University Hospital
Edegem, Antwerp, 2650
Jonathan Mertens, M.D., +328217304, jonathan.mertens@uza.be
About this study
Official title: Prevalence, Incidence and Characteristics of NAFLD/NASH in Type 1 Diabetes Mellitus Obtained Via a Non-invasive Screening Protocol
Nonalcoholic fatty liver disease (NAFLD) is a condition characterized by intrahepatic fat accumulation. It is closely related to insulin resistance. To date, it remains unclear whether NAFLD is common in patients with type 1 diabetes or if NAFLD translates into an increased health burden in this population. Screening for NAFLD is challenging due to the limitations of non-invasive diagnostic tools.
Liver biopsy remains the gold standard but is not suited for routine screening or clinical studies. Therefore, there is a great demand for accurate non-invasive screening tools that can not only diagnose but also stage NAFLD. This study aims to generate a large cohort of thoroughly characterized type 1 diabetes patients screened for NAFLD using multiple non-invasive tools including MRI, ultrasound, controlled attenuation parameter, and score panels. We aim to generate a biobank to promote a research collaboration network in the field of non-invasive diagnosis of NAFLD.
A secondary endpoint is to investigate the potential correlation between the presence of NAFLD and the occurrence of micro-or macrovascular complications in patients with diabetes.
Read the detailed description
This study aims to characterize and follow a thoroughly characterized cohort of adult type 1 diabetes patients free from secondary liver disease due to excessive alcohol usage, viral hepatitis, alfa-1 antitrypsin deficiency, Wilson's disease or steatogenic or hepatotoxic drug use.
The investigators will screen for NAFLD and fibrosis using multiple non-invasive techniques including
- ultrasound
- controlled attenuation parameter
- fatty liver index
- human steatosis index
- transient elastography
- FIB-4
- NAFLD fibrosis score
- NASH algorithm based on multiple parameters
Subjects will be screened for microvascular and microvascular complications with:
- ECG
- microfilament examination
- 24hour urine collection for microalbuminuria
- serum kidney test (creatinine, eGFR)
- fundoscopy
- peripheral arterial pulsation palpation
The investigators will subsequently thoroughly characterize various metabolic and anthropometric parameters and document any microvascular or macrovascular complications.
The patients will be annually rescreened for both NAFLD-related as cardiovascular variables. Therefore this study will assess the correlation between NAFLD, cardiovascular risk, and type 1 diabetes in a prospective manner.
- Conditions
- NAFLD, Type 1 Diabetes, Cardiovascular Diseases
- Being tested
- ultrasound, elastography, controlled attenuation parameter (CAP), FLI, FIB-4
- Keywords
- NAFLD, type 1 diabetes, cardiovascular disease, insulin resistance
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 1, Cardiovascular Diseases, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDiagnostic test
ultrasound to check for NAFLD according to Saverymuttu criteria
elastographyDiagnostic test
elastography to compare liver stiffness indices
controlled attenuation parameter (CAP)Diagnostic test
CAP is a non-invasive additive on Fibroscan (trademark) which can quantify hepatic steatosis
FLIDiagnostic test
the FLI is a score panel designed to screen for NAFLD
FIB-4Diagnostic test
the FIB-4 is a score panel designed to screen for significant fibrosis
NFSDiagnostic test
the NFS is a score panel designed to screen for significant fibrosis
| Study group | Role | What they receive |
|---|---|---|
| NAFLD + type 1 diabetes | type 1 diabetes patient with NAFLD on screening Receives: Diagnostic Test: ultrasound; Diagnostic Test: elastography; Diagnostic Test: controlled attenuation parameter (CAP); Diagnostic Test: FLI; Diagnostic Test: FIB-4; Diagnostic Test: NFS | |
| noNAFLD + type 1 diabetes | type 1 diabetes patient without NAFLD on screening Receives: Diagnostic Test: ultrasound; Diagnostic Test: elastography; Diagnostic Test: controlled attenuation parameter (CAP); Diagnostic Test: FLI; Diagnostic Test: FIB-4; Diagnostic Test: NFS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of NAFLD in type 1 diabetes: percentage of patients with indices of liver steatosis and/or NASH and/or fibrosis.
Determination of the cross-sectional prevalence of NAFLD in a cohort of type 1 diabetes patient (population size approximately 1000 subjects) according to ultrasound criteria, FLI≥60, HSI≥36, controlled attenuation parameter >215dB/m (M-probe) or ≥250 dB/m (XL probe) and MRI-PDFF >5% hepatocyte steatosis (reference method). All measures will be performed in a combined and standardized protocol to explore their diagnostic accuracy (see outcome 4).
Measured: one year
Incidence of NAFLD in type 1 diabetes.
Incidence of NAFLD in type 1 diabetes determined by new cases of NAFLD according to ultrasound criteria, FLI≥60, HSI≥36, controlled attenuation parameter >215dB/m (M-probe) or ≥250 dB/m (XL probe) or MRI-PDFF >5% hepatocyte fat infiltration (reference method)
Measured: five years
correlation of NAFLD with microvascular and macrovascular complications in type 1 diabetes mellitus: odds ratio to have prevalent complications in NAFLD and diabetes compared to diabetes without NAFLD
The correlation between indices of microvascular (neuropathy assessed by microfilament test, nephropathy assessed by microalbuminuria rate and retinopathy assessed by fundoscopic criteria) or macrovascular (non-fatal ischemic coronary disease, non-fatal cerebrovascular disease, non-fatal peripheral artery disease, or mortality due to cardiovascular disease) complications will be compared between groups with and without NAFLD as determined by the abovementioned screening tools.
Measured: one year
Association of NAFLD with microvascular and macrovascular complications in type 1 diabetes mellitus: odds ratio to develop in NAFLD and diabetes compared to diabetes without NAFLD in subjects with no prior complications
The association between indices of microvascular (neuropathy assessed by microfilament test, nephropathy assessed by microalbuminuria rate and retinopathy assessed by fundoscopic criteria) or macrovascular (non-fatal ischemic coronary disease, non-fatal cerebrovascular disease, non-fatal peripheral artery disease or mortality due to cardiovascular disease) complications will be assessed between groups with and without NAFLD, but all without prior micro- or macrovascular disease as determined by the abovementioned screening tools.
Measured: five years
Secondary outcomes (2)
Diagnostic accuracy of non-invasive tools for NAFLD in type 1 diabetes: comparison of AUROC and diagnostic accuracy
The investigators will compare the abovementioned non-invasive tools to diagnose and grade liver steatosis and fibrosis with the predefined gold standard (MRI-PDFF for steatosis and magnetic resonance elastography for fibrosis). Correlations and agreement statistics will be performed for each index. Using regression analysis, a new specific algorithm will be developed based on cohort-specific cutoffs. Using longitudinal data, a prediction score will be determined to predict NAFLD occurrence or NAFLD progression.
Measured: five years
Natural history of NAFLD in type 1 diabetes
Timewise description of the progression of quantitative indices of liver steatosis and fibrosis on the abovementioned tools (ultrasound, score systems, elastography) to assess the natural evolution of NAFLD. Every year this assay will be performed. MRI-PDFF will be performed in 5 years as a reference method to mark the five-year follow-up window
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start17 Sep 2018
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christophe De Block, University Hospital, Antwerp
- Investigators
- Christophe De Block, M.D., PhD, Principal investigator, Universiteit AntwerpenSven Francque, M.D., PhD, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664036
- Sponsor's protocol ID
- 18/32/361
- Acronym
- NAFLDIA1
- Status last verified
- Mar 2022
- First submitted
- 4 Nov 2020
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: monocentric study
Publications
de Vries M, Westerink J, Kaasjager KHAH, de Valk HW. Prevalence of Nonalcoholic Fatty Liver Disease (NAFLD) in Patients With Type 1 Diabetes Mellitus: A Systematic Review and Meta-Analysis. J Clin Endocrinol Metab. 2020 Dec 1;105(12):3842-53. doi: 10.1210/clinem/dgaa575.
PubMed 32827432Tana C, Ballestri S, Ricci F, Di Vincenzo A, Ticinesi A, Gallina S, Giamberardino MA, Cipollone F, Sutton R, Vettor R, Fedorowski A, Meschi T. Cardiovascular Risk in Non-Alcoholic Fatty Liver Disease: Mechanisms and Therapeutic Implications. Int J Environ Res Public Health. 2019 Aug 26;16(17):3104. doi: 10.3390/ijerph16173104.
PubMed 31455011European Association for the Study of the Liver (EASL); European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO). EASL-EASD-EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease. J Hepatol. 2016 Jun;64(6):1388-402. doi: 10.1016/j.jhep.2015.11.004. Epub 2016 Apr 7. No abstract available.
PubMed 27062661Ismaiel A, Dumitrascu DL. Cardiovascular Risk in Fatty Liver Disease: The Liver-Heart Axis-Literature Review. Front Med (Lausanne). 2019 Sep 13;6:202. doi: 10.3389/fmed.2019.00202. eCollection 2019.
PubMed 31616668De Block CEM, Shivalkar B, Goovaerts W, Brits T, Carpentier K, Verrijken A, Van Hoof V, Parizel PM, Vrints C, Van Gaal LF. Coronary artery calcifications and diastolic dysfunction versus visceral fat area in type 1 diabetes: VISCERA study. J Diabetes Complications. 2018 Mar;32(3):271-278. doi: 10.1016/j.jdiacomp.2017.11.008. Epub 2017 Nov 28.
PubMed 29310998Hampson SJ. Nursing interventions for the first three postpartum months. J Obstet Gynecol Neonatal Nurs. 1989 Mar-Apr;18(2):116-22. doi: 10.1111/j.1552-6909.1989.tb00474.x.
PubMed 2709179Aernouts C, Belde SPW, Lambrechts J, Mertens J, Ledeganck KJ, Francque SM, De Block CEM. Metabolic dysfunction-associated steatotic liver disease is associated with worse time in ranges in type 1 diabetes. Diabetes Obes Metab. 2024 Sep;26(9):3781-3790. doi: 10.1111/dom.15723. Epub 2024 Jun 25.
PubMed 38924290
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Incidence and Characteristics of NAFLD/NASH in Type 1 Diabetes Mellitus Obtained Via a Non-invasive Screening Protocol
- ClinicalTrials.gov ID
- NCT04664036
- Acronym / sponsor ID
- NAFLDIA1 / 18/32/361
- Conditions
- NAFLD, Type 1 Diabetes, Cardiovascular Diseases
- Keywords
- NAFLD, type 1 diabetes, cardiovascular disease, insulin resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 11 Dec 2020 (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.
Nonalcoholic fatty liver disease (NAFLD) is a condition characterized by intrahepatic fat accumulation. It is closely related to insulin resistance. To date, it remains unclear whether NAFLD is common in patients with type 1 diabetes or if NAFLD translates into an increased health burden in this population. Screening for NAFLD is challenging due to the limitations of non-invasive diagnostic tools.
Liver biopsy remains the gold standard but is not suited for routine screening or clinical studies. Therefore, there is a great demand for accurate non-invasive screening tools that can not only diagnose but also stage NAFLD. This study aims to generate a large cohort of thoroughly characterized type 1 diabetes patients screened for NAFLD using multiple non-invasive tools including MRI, ultrasound, controlled attenuation parameter, and score panels. We aim to generate a biobank to promote a research collaboration network in the field of non-invasive diagnosis of NAFLD.
A secondary endpoint is to investigate the potential correlation between the presence of NAFLD and the occurrence of micro-or macrovascular complications in patients with diabetes.
Detailed description
This study aims to characterize and follow a thoroughly characterized cohort of adult type 1 diabetes patients free from secondary liver disease due to excessive alcohol usage, viral hepatitis, alfa-1 antitrypsin deficiency, Wilson's disease or steatogenic or hepatotoxic drug use.
The investigators will screen for NAFLD and fibrosis using multiple non-invasive techniques including
- ultrasound
- controlled attenuation parameter
- fatty liver index
- human steatosis index
- transient elastography
- FIB-4
- NAFLD fibrosis score
- NASH algorithm based on multiple parameters
Subjects will be screened for microvascular and microvascular complications with:
- ECG
- microfilament examination
- 24hour urine collection for microalbuminuria
- serum kidney test (creatinine, eGFR)
- fundoscopy
- peripheral arterial pulsation palpation
The investigators will subsequently thoroughly characterize various metabolic and anthropometric parameters and document any microvascular or macrovascular complications.
The patients will be annually rescreened for both NAFLD-related as cardiovascular variables. Therefore this study will assess the correlation between NAFLD, cardiovascular risk, and type 1 diabetes in a prospective manner.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAFLD + type 1 diabetes | – | Diagnostic Test: ultrasound, Diagnostic Test: elastography, Diagnostic Test: controlled attenuation parameter (CAP), Diagnostic Test: FLI, Diagnostic Test: FIB-4, Diagnostic Test: NFStype 1 diabetes patient with NAFLD on screening |
| noNAFLD + type 1 diabetes | – | Diagnostic Test: ultrasound, Diagnostic Test: elastography, Diagnostic Test: controlled attenuation parameter (CAP), Diagnostic Test: FLI, Diagnostic Test: FIB-4, Diagnostic Test: NFStype 1 diabetes patient without NAFLD on screening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult type 1 diabetes patients followed in the outpatient diabetes clinic of the Antwerp University Hospital
Key inclusion criteria (3 listed)
- Type 1 diabetes
- Adult age
- Informed consent given
Key exclusion criteria (6 listed)
- Secondary liver disease
- Excess alcohol usage
- Pregnancy
- Use of steatogenic medication
- Active cancer or oncological treatment
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 |
|---|---|---|
| ultrasoundultrasound to check for NAFLD according to Saverymuttu criteria | Diagnostic test | NAFLD + type 1 diabetes, noNAFLD + type 1 diabetes |
| elastographyelastography to compare liver stiffness indices | Diagnostic test | NAFLD + type 1 diabetes, noNAFLD + type 1 diabetes |
| controlled attenuation parameter (CAP)CAP is a non-invasive additive on Fibroscan (trademark) which can quantify hepatic steatosis | Diagnostic test | NAFLD + type 1 diabetes, noNAFLD + type 1 diabetes |
| FLIthe FLI is a score panel designed to screen for NAFLD | Diagnostic test | NAFLD + type 1 diabetes, noNAFLD + type 1 diabetes |
| FIB-4the FIB-4 is a score panel designed to screen for significant fibrosis | Diagnostic test | NAFLD + type 1 diabetes, noNAFLD + type 1 diabetes |
| NFSthe NFS is a score panel designed to screen for significant fibrosis | Diagnostic test | NAFLD + type 1 diabetes, noNAFLD + type 1 diabetes |
Primary outcome
Prevalence of NAFLD in type 1 diabetes: percentage of patients with indices of liver steatosis and/or NASH and/or fibrosis.
Time frame: one year
Determination of the cross-sectional prevalence of NAFLD in a cohort of type 1 diabetes patient (population size approximately 1000 subjects) according to ultrasound criteria, FLI≥60, HSI≥36, controlled attenuation parameter >215dB/m (M-probe) or ≥250 dB/m (XL probe) and MRI-PDFF >5% hepatocyte steatosis (reference method). All measures will be performed in a combined and standardized protocol to explore their diagnostic accuracy (see outcome 4).
Incidence of NAFLD in type 1 diabetes.
Time frame: five years
Incidence of NAFLD in type 1 diabetes determined by new cases of NAFLD according to ultrasound criteria, FLI≥60, HSI≥36, controlled attenuation parameter >215dB/m (M-probe) or ≥250 dB/m (XL probe) or MRI-PDFF >5% hepatocyte fat infiltration (reference method)
correlation of NAFLD with microvascular and macrovascular complications in type 1 diabetes mellitus: odds ratio to have prevalent complications in NAFLD and diabetes compared to diabetes without NAFLD
Time frame: one year
The correlation between indices of microvascular (neuropathy assessed by microfilament test, nephropathy assessed by microalbuminuria rate and retinopathy assessed by fundoscopic criteria) or macrovascular (non-fatal ischemic coronary disease, non-fatal cerebrovascular disease, non-fatal peripheral artery disease, or mortality due to cardiovascular disease) complications will be compared between groups with and without NAFLD as determined by the abovementioned screening tools.
Association of NAFLD with microvascular and macrovascular complications in type 1 diabetes mellitus: odds ratio to develop in NAFLD and diabetes compared to diabetes without NAFLD in subjects with no prior complications
Time frame: five years
The association between indices of microvascular (neuropathy assessed by microfilament test, nephropathy assessed by microalbuminuria rate and retinopathy assessed by fundoscopic criteria) or macrovascular (non-fatal ischemic coronary disease, non-fatal cerebrovascular disease, non-fatal peripheral artery disease or mortality due to cardiovascular disease) complications will be assessed between groups with and without NAFLD, but all without prior micro- or macrovascular disease as determined by the abovementioned screening tools.
2 secondary outcomes
Diagnostic accuracy of non-invasive tools for NAFLD in type 1 diabetes: comparison of AUROC and diagnostic accuracy
Time frame: five years
Natural history of NAFLD in type 1 diabetes
Time frame: five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Background: PubMed 32827432de Vries M, Westerink J, Kaasjager KHAH, de Valk HW. Prevalence of Nonalcoholic Fatty Liver Disease (NAFLD) in Patients With Type 1 Diabetes Mellitus: A Systematic Review and Meta-Analysis. J Clin Endocrinol Metab. 2020 Dec 1;105(12):3842-53. doi: 10.1210/clinem/dgaa575.
- Background: PubMed 31455011Tana C, Ballestri S, Ricci F, Di Vincenzo A, Ticinesi A, Gallina S, Giamberardino MA, Cipollone F, Sutton R, Vettor R, Fedorowski A, Meschi T. Cardiovascular Risk in Non-Alcoholic Fatty Liver Disease: Mechanisms and Therapeutic Implications. Int J Environ Res Public Health. 2019 Aug 26;16(17):3104. doi: 10.3390/ijerph16173104.
- Background: PubMed 27062661European Association for the Study of the Liver (EASL); European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO). EASL-EASD-EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease. J Hepatol. 2016 Jun;64(6):1388-402. doi: 10.1016/j.jhep.2015.11.004. Epub 2016 Apr 7. No abstract available.
- Background: PubMed 31616668Ismaiel A, Dumitrascu DL. Cardiovascular Risk in Fatty Liver Disease: The Liver-Heart Axis-Literature Review. Front Med (Lausanne). 2019 Sep 13;6:202. doi: 10.3389/fmed.2019.00202. eCollection 2019.
- Background: PubMed 29310998De Block CEM, Shivalkar B, Goovaerts W, Brits T, Carpentier K, Verrijken A, Van Hoof V, Parizel PM, Vrints C, Van Gaal LF. Coronary artery calcifications and diastolic dysfunction versus visceral fat area in type 1 diabetes: VISCERA study. J Diabetes Complications. 2018 Mar;32(3):271-278. doi: 10.1016/j.jdiacomp.2017.11.008. Epub 2017 Nov 28.
- Background: PubMed 2709179Hampson SJ. Nursing interventions for the first three postpartum months. J Obstet Gynecol Neonatal Nurs. 1989 Mar-Apr;18(2):116-22. doi: 10.1111/j.1552-6909.1989.tb00474.x.
- Derived from this study: PubMed 38924290Aernouts C, Belde SPW, Lambrechts J, Mertens J, Ledeganck KJ, Francque SM, De Block CEM. Metabolic dysfunction-associated steatotic liver disease is associated with worse time in ranges in type 1 diabetes. Diabetes Obes Metab. 2024 Sep;26(9):3781-3790. doi: 10.1111/dom.15723. Epub 2024 Jun 25.
- Individual participant dataSharing planned: No. monocentric study
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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.
Rie Braspenning, nurse contact
Christophe De Block, M.D., PhD principal investigator
Universiteit Antwerpen
Sven Francque, M.D., PhD principal investigator
Universiteit Antwerpen
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 NAFLD and Type 1 Diabetes, run by University Hospital, Antwerp at 1 site in Belgium.
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: status not confirmed, as of the sponsor's last update on 4 Mar 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Mertens, M.D. (+328217304, jonathan.mertens@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of NAFLD in type 1 diabetes: percentage of patients with indices of liver steatosis and/or NASH and/or fibrosis. (time frame: one year). The study lists 4 primary outcomes in all. 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 NCT04664036, which also lists 7 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 4 Mar 2022.