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

3 mars 2022 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Förväntat)

700

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Belgien
    • Antwerp
      • Edegem, Antwerp, Belgien, 2650
        • Rekrytering
        • Antwerp University Hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Prevalence of NAFLD in type 1 diabetes: percentage of patients with indices of liver steatosis and/or NASH and/or fibrosis.
Tidsram: 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.
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Diagnostic accuracy of non-invasive tools for NAFLD in type 1 diabetes: comparison of AUROC and diagnostic accuracy
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University Hospital, Antwerp

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

17 september 2018

Primärt slutförande (Förväntat)

30 juli 2023

Avslutad studie (Förväntat)

30 juli 2025

Studieregistreringsdatum

Först inskickad

4 november 2020

Först inskickad som uppfyllde QC-kriterierna

10 december 2020

Första postat (Faktisk)

11 december 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 mars 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 mars 2022

Senast verifierad

1 mars 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 18/32/361

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

monocentric study

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

produkt tillverkad i och exporterad från U.S.A.

Nej

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