Prevalence and Risk Factors of Metabolic-Associated Hepatic Steatosis in Individuals Living With Type 1 Diabetes

N/ANot Yet RecruitingNCT07475962

Institut de Recherches Cliniques de Montreal100 enrolled

Overview

The goal of this observational cross-sectional study is to assess the prevalence and stage of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), specifically liver steatosis and fibrosis in adults aged 18 and older living with type 1 diabetes or Latent Autoimmune Diabetes in Adults (LADA) in Quebec. The main questions it aims to answer are: 1. What is the prevalence and severity of liver steatosis and fibrosis among people living with type 1 diabetes in Québec? 2. Are there patients with type 1 diabetes who have advanced, undiagnosed stages of liver disease that require management but are missed by current standard care practices? Researchers will compare three participant subgroups based on adiposity (a control group without increased adiposity, an overweight group with increased adiposity, and an obesity group with increased adiposity) to see if the prevalence and severity of hepatic steatosis and fibrosis are highest in the obesity group and lowest in the control group. They will also explore if variables and potential risk factors associated with liver disease differ across these subgroups. Participants will attend a single study visit where they will be asked to: * Provide clinical data through laboratory analyses. * Undergo specific clinical procedures. * Complete validated questionnaires.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Type 1 Diabetes Liver Steatoses MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease Liver Fibrosis

Interventions

Adiposity and BMI ClassificationOTHER

Participants are classified into three subgroups based on their BMI and the presence of increased adiposity. Increased adiposity is defined by waist circumference, waist-to-hip ratio, or waist-to-height ratio exceeding sex- and ethnicity-specific thresholds. The subgroups are: a control group (no increased adiposity), an overweight group (BMI 25.0-29.9 kg/m² with increased adiposity), and an obesity group (BMI ≥ 30 kg/m² with increased adiposity).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Assessment of liver fibrosis using FibroScan

Liver fibrosis severity will be quantified using liver stiffness measurement (LSM) obtained via FibroScan. The measurement is expressed in kilopascals (kPa). Higher values indicate more severe fibrosis, categorized as: \< 8.0 kPa (Normal), 8.0 to 9.6 kPa (Significant fibrosis), 9.7 to 13.5 kPa (Advanced fibrosis), and \> 13.5 kPa (Cirrhosis)