Prevalence, Incidence and Characteristics of NAFLD/NASH in Type 1 Diabetes Mellitus
NCT ID: NCT04664036
Last Updated: 2022-03-04
Study Results
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Basic Information
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UNKNOWN
700 participants
OBSERVATIONAL
2018-09-17
2025-07-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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NAFLD + type 1 diabetes
type 1 diabetes patient with NAFLD on screening
ultrasound
ultrasound to check for NAFLD according to Saverymuttu criteria
elastography
elastography to compare liver stiffness indices
controlled attenuation parameter (CAP)
CAP is a non-invasive additive on Fibroscan (trademark) which can quantify hepatic steatosis
FLI
the FLI is a score panel designed to screen for NAFLD
FIB-4
the FIB-4 is a score panel designed to screen for significant fibrosis
NFS
the NFS is a score panel designed to screen for significant fibrosis
noNAFLD + type 1 diabetes
type 1 diabetes patient without NAFLD on screening
ultrasound
ultrasound to check for NAFLD according to Saverymuttu criteria
elastography
elastography to compare liver stiffness indices
controlled attenuation parameter (CAP)
CAP is a non-invasive additive on Fibroscan (trademark) which can quantify hepatic steatosis
FLI
the FLI is a score panel designed to screen for NAFLD
FIB-4
the FIB-4 is a score panel designed to screen for significant fibrosis
NFS
the NFS is a score panel designed to screen for significant fibrosis
Interventions
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ultrasound
ultrasound to check for NAFLD according to Saverymuttu criteria
elastography
elastography to compare liver stiffness indices
controlled attenuation parameter (CAP)
CAP is a non-invasive additive on Fibroscan (trademark) which can quantify hepatic steatosis
FLI
the FLI is a score panel designed to screen for NAFLD
FIB-4
the FIB-4 is a score panel designed to screen for significant fibrosis
NFS
the NFS is a score panel designed to screen for significant fibrosis
Eligibility Criteria
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Inclusion Criteria
* Adult age
* Informed consent given
Exclusion Criteria
* Excess alcohol usage
* Pregnancy
* Use of steatogenic medication
* Active cancer or oncological treatment
* History of organ transplantation
18 Years
ALL
No
Sponsors
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University Hospital, Antwerp
OTHER
Responsible Party
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Christophe De Block
Prof. dr. Christophe De Block
Principal Investigators
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Christophe De Block, M.D., PhD
Role: PRINCIPAL_INVESTIGATOR
Universiteit Antwerpen
Sven Francque, M.D., PhD
Role: PRINCIPAL_INVESTIGATOR
Universiteit Antwerpen
Locations
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Antwerp University Hospital
Edegem, Antwerp, Belgium
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Tana 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.
European 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.
Ismaiel 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.
De 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.
Hampson 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.
Other Identifiers
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18/32/361
Identifier Type: -
Identifier Source: org_study_id
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