STEA-DT1Prevalence and Severity of Liver Steatosis and Fibrosis in Type 1 Diabetes Patients
This observational study aims to measure the prevalence and severity of liver steatosis and fibrosis in patients with Type 1 Diabetes, using FibroScan to assess both liver stiffness for fibrosis and Controlled Attenuation Parameter for steatosis.
Data Collection
Collected at a single point in time - Cross-sectionalAutoimmune Diseases+12
+ Diabetes Mellitus
+ Diabetes Mellitus, Type 1
Other
Utilizing specific methods not covered by standard models in order to address unique research questions.Summary
Study start date: April 1, 2026
Actual date on which the first participant was enrolled.This study focuses on understanding the prevalence and severity of a liver condition called Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), specifically liver steatosis and fibrosis, among adults living with type 1 diabetes or Latent Autoimmune Diabetes in Adults (LADA) in Quebec. The research aims to identify if there are individuals with type 1 diabetes who have advanced, undiagnosed stages of liver disease that require management but are missed by current standard care practices. It also seeks to compare different groups based on adiposity to see if the prevalence and severity of hepatic steatosis and fibrosis vary among these groups. Participants in this study will attend a single visit where they will provide clinical data through laboratory analyses, undergo specific clinical procedures, and complete validated questionnaires. The primary outcomes of the study involve assessing liver fibrosis using a method called FibroScan, which measures liver stiffness to determine the severity of fibrosis. Additionally, the degree of liver steatosis will be assessed using a measure called the Controlled Attenuation Parameter (CAP) value, which is generated simultaneously during the FibroScan assessment.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Individuals ≥ 18 years of age. * A clinical diagnosis of type 1 diabetes or Latent Autoimmune Diabetes in Adults (LADA) for at least one year, as per the investigators' clinical judgment (confirmatory C-peptide and antibodies will not be required). Exclusion Criteria: * Alcohol consumption exceeding 20g per day in women or 30g per day in men. * Known chronic liver disease (including viral, drug-induced, Wilson disease, deficit in alpha-1-antirypsin, hemochromatosis, autoimmune hepatitis, etc.). * Evidence of cirrhosis based on a result of liver biopsy, or history of portal hypertension presented by ascites, hepatic encephalopathy or varices. * History of use of medications known to induce liver steatosis, including corticosteroids, high-dose estrogens, tamoxifen, methotrexate, amiodarone, or tetracycline. * Ongoing pregnancy. * Life expectancy of less than 5 years, as per investigators' clinical judgment.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives