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

Antwerp University Hospital (UZA)

Status: Enrolling

Conditions: Type 1 Diabetes; Cardiovascular Diseases; NAFLD

Treatments: Diagnostic Test: NFS; Diagnostic Test: elastography; Diagnostic Test: controlled attenuation parameter (CAP); Diagnostic Test: FIB-4; Diagnostic Test: FLI; Diagnostic Test: ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT04664036

18/32/361

Details and patient eligibility

About

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.

Full 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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

700 participants in 2 patient groups

NAFLD + type 1 diabetes

Description:

type 1 diabetes patient with NAFLD on screening

Treatment:

Diagnostic Test: FIB-4

Diagnostic Test: NFS

Diagnostic Test: FLI

Diagnostic Test: elastography

Diagnostic Test: ultrasound

Diagnostic Test: controlled attenuation parameter (CAP)

noNAFLD + type 1 diabetes

Description:

type 1 diabetes patient without NAFLD on screening

Treatment:

Diagnostic Test: FIB-4

Diagnostic Test: NFS

Diagnostic Test: FLI

Diagnostic Test: elastography

Diagnostic Test: ultrasound

Diagnostic Test: controlled attenuation parameter (CAP)