Brief 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

700

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Sep 2018

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

6.9 years study duration

Study Start

First participant enrolled

September 17, 2018

Completed

2.1 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2020

Completed

1 month until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed

Last Updated

March 4, 2022

Status Verified

March 1, 2022

Enrollment Period

4.9 years

First QC Date

November 4, 2020

Last Update Submit

March 3, 2022

Conditions

NAFLD Type 1 Diabetes Cardiovascular Diseases

Keywords

NAFLDtype 1 diabetescardiovascular diseaseinsulin resistance

Outcome Measures

Primary Outcomes (4)

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

Secondary Outcomes (2)

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

Study Arms (2)

NAFLD + type 1 diabetes

type 1 diabetes patient with NAFLD on screening

Diagnostic Test: ultrasoundDiagnostic Test: elastographyDiagnostic Test: controlled attenuation parameter (CAP)Diagnostic Test: FLIDiagnostic Test: FIB-4Diagnostic Test: NFS

noNAFLD + type 1 diabetes

type 1 diabetes patient without NAFLD on screening

Diagnostic Test: ultrasoundDiagnostic Test: elastographyDiagnostic Test: controlled attenuation parameter (CAP)Diagnostic Test: FLIDiagnostic Test: FIB-4Diagnostic Test: NFS