Last reviewed · How we verify
NCT04664036: NAFLDIA1
Prevalence, Incidence and Characteristics of NAFLD/NASH in Type 1 Diabetes Mellitus
trial testing ultrasound in NAFLD in 700 participants. Status unknown.
30 July 2023
Quick facts
| Lead sponsor | University Hospital, Antwerp |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 700 |
| Start date | 17 September 2018 |
| Primary completion | 30 July 2023 |
| Estimated completion | 30 July 2025 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- ultrasound
- elastography
- controlled attenuation parameter (CAP)
- FLI
- FIB-4
- NFS
Conditions studied
- NAFLD — all drugs for NAFLD →
- Type 1 Diabetes — all drugs for Type 1 Diabetes →
- Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
Sponsor
University Hospital, Antwerp
Who can join
18 and older, any sex, with NAFLD or Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
57<sup>th</sup> EASD Annual Meeting of the European Association for the Study of Diabetes.
· 2021 · cited 11× · PMID 34468792 · DOI 10.1007/s00125-021-05519-y -
Insulin Resistance and CGM-Derived Parameters in People With Type 1 Diabetes: Are They Associated?
Clinck I, Mertens J, Wouters K, Dirinck E, et al · · 2024 · cited 7× · PMID 38198792 · DOI 10.1210/clinem/dgae015 -
Increased prevalence and risk of atherosclerotic cardiovascular disease in individuals with Type 1 diabetes and metabolic dysfunction-associated steatotic liver disease.
Mertens J, Weyler J, Dirinck E, Vonghia L, et al · · 2025 · cited 6× · PMID 40442720 · DOI 10.1186/s12933-025-02764-y -
Relationship between liver and cardiometabolic health in type 1 diabetes.
Tas E, Vu BK, Mendizabal B, Libman I, et al · · 2024 · cited 1× · PMID 39605938 · DOI 10.3389/fendo.2024.1505430
Verify or expand the search:
- PubMed search for NCT04664036
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University Hospital, Antwerp trials
Trials by the same sponsor.
- NCT07455422 — A Study of Barrett's Esophagus Patients: Optimization of a Risk Model to Better Predict the Development of Cancer Recurr · NA · not yet recruiting
- NCT07020715 — A Phase IIa Study of Vitamin D3 Tolerogenic Dendritic Cells (tolDC) for Multiple Sclerosis · Phase 2 · not yet recruiting
- NCT07443761 — Patients Undergoing Pancreatic Surgery at the Antwerp University Hospital. · active not recruiting
- NCT06372847 — DISE-HNS Effect Study · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04664036 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Antwerp
- Last refreshed: 4 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04664036.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing