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

Summary

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.

Conditions

• NAFLD
• Type 1 Diabetes
• Cardiovascular Diseases

Interventions

DIAGNOSTIC_TEST

ultrasound

ultrasound to check for NAFLD according to Saverymuttu criteria

DIAGNOSTIC_TEST

elastography

elastography to compare liver stiffness indices

DIAGNOSTIC_TEST

controlled attenuation parameter (CAP)

CAP is a non-invasive additive on Fibroscan (trademark) which can quantify hepatic steatosis

DIAGNOSTIC_TEST

FLI

the FLI is a score panel designed to screen for NAFLD

DIAGNOSTIC_TEST

FIB-4

the FIB-4 is a score panel designed to screen for significant fibrosis

DIAGNOSTIC_TEST

NFS

the NFS is a score panel designed to screen for significant fibrosis

Sponsors & Collaborators

• University Hospital, Antwerp

  lead OTHER

Principal Investigators

• Christophe De Block, M.D., PhD · Universiteit Antwerpen

• Sven Francque, M.D., PhD · Universiteit Antwerpen

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-17

Primary Completion

2023-07-30

Completion

2025-07-30

FDA Device

Yes

Countries

• Belgium

Study Locations