NCT04664036

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

Prevalence, Incidence and Characteristics of NAFLD/NASH in Type 1 Diabetes Mellitus Obtained Via a Non-invasive Screening Protocol

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 700 (estimated)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• NAFLD
• Type 1 Diabetes
• Cardiovascular Diseases

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-09-17
• Primary completion: 2023-07-30
• Completion: 2025-07-30
• First posted: 2020-12-11
• Last updated: 2022-03-04

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated device study