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Prevalence, Incidence and Characteristics of NAFLD/NASH in Type 1 Diabetes Mellitus (NAFLDIA1)

3. mars 2022 oppdatert av: Christophe De Block, University Hospital, Antwerp

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

700

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Belgia
    • Antwerp
      • Edegem, Antwerp, Belgia, 2650
        • Rekruttering
        • Antwerp University Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Adult type 1 diabetes patients followed in the outpatient diabetes clinic of the Antwerp University Hospital

Beskrivelse

Inclusion Criteria:

  • Type 1 diabetes
  • Adult age
  • Informed consent given

Exclusion Criteria:

  • Secondary liver disease
  • Excess alcohol usage
  • Pregnancy
  • Use of steatogenic medication
  • Active cancer or oncological treatment
  • History of organ transplantation

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
NAFLD + type 1 diabetes
type 1 diabetes patient with NAFLD on screening
Diagnostisk test: ultrasound
ultrasound to check for NAFLD according to Saverymuttu criteria
Diagnostisk test: elastography
elastography to compare liver stiffness indices
Diagnostisk test: controlled attenuation parameter (CAP)
CAP is a non-invasive additive on Fibroscan (trademark) which can quantify hepatic steatosis
Diagnostisk test: FLI
the FLI is a score panel designed to screen for NAFLD
Diagnostisk test: FIB-4
the FIB-4 is a score panel designed to screen for significant fibrosis
Diagnostisk test: 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
Diagnostisk test: ultrasound
ultrasound to check for NAFLD according to Saverymuttu criteria
Diagnostisk test: elastography
elastography to compare liver stiffness indices
Diagnostisk test: controlled attenuation parameter (CAP)
CAP is a non-invasive additive on Fibroscan (trademark) which can quantify hepatic steatosis
Diagnostisk test: FLI
the FLI is a score panel designed to screen for NAFLD
Diagnostisk test: FIB-4
the FIB-4 is a score panel designed to screen for significant fibrosis
Diagnostisk test: NFS
the NFS is a score panel designed to screen for significant fibrosis

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prevalence of NAFLD in type 1 diabetes: percentage of patients with indices of liver steatosis and/or NASH and/or fibrosis.
Tidsramme: 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).
one year
Incidence of NAFLD in type 1 diabetes.
Tidsramme: 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)
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
Tidsramme: 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.
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
Tidsramme: 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.
five years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Diagnostic accuracy of non-invasive tools for NAFLD in type 1 diabetes: comparison of AUROC and diagnostic accuracy
Tidsramme: five years
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.
five years
Natural history of NAFLD in type 1 diabetes
Tidsramme: five years
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
five years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital, Antwerp

Etterforskere

  • Hovedetterforsker: Christophe De Block, M.D., PhD, Universiteit Antwerpen
  • Hovedetterforsker: Sven Francque, M.D., PhD, Universiteit Antwerpen

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

17. september 2018

Primær fullføring (Forventet)

30. juli 2023

Studiet fullført (Forventet)

30. juli 2025

Datoer for studieregistrering

Først innsendt

4. november 2020

Først innsendt som oppfylte QC-kriteriene

10. desember 2020

Først lagt ut (Faktiske)

11. desember 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. mars 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. mars 2022

Sist bekreftet

1. mars 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 18/32/361

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

monocentric study

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

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