Latent Autoimmune Diabetes in Adult (LADA), Liver Fibrosis, Liver Steatoses, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Type 1 Diabetes
Conditions
Keywords
MASLD, Liver steatosis, Liver fibrosis, LADA, Body composition, Type 1 diabetes
Brief summary
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.
Interventions
OTHERAdiposity and BMI Classification
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).
Sponsors
Institut de Recherches Cliniques de Montreal
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of liver fibrosis using FibroScan | Baseline (Day 1 / Single Study Visit) | 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) |
| Degree of liver steatosis assessment | Baseline (Day 1 / Single Study Visit) | Liver steatosis will be quantified using the Controlled Attenuation Parameter CAP value generated simultaneously during the FibroScan assessment. The measurement is expressed in decibels per meter (dB/m). Higher values indicate a higher degree of steatosis, categorized as: \< 294 dB/m (\<5% steatosis), 294 to 310 dB/m (5 to 30%), 311 to 330 dB/m (30 to 60%), and \> 330 dB/m (\>60%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anthropometric Assessment: Body mass Index (BMI) | Baseline (Day 1 / Single Study Visit) | Body mass index (BMI: kg/m\^2) will be calculated using weight (kg) and height (cm) to compare FibroScan results across predefined subgroups. |
| Anthropometric Assessment: Waist circumference | Baseline (Day 1 / Single Study Visit) | Waist circumference and hip circumference (cm) will be used to compare FibroScan results across predefined subgroups. |
| Adiposity-Based Subgroup Classification | Baseline (Day 1 / Single Study Visit) | Participants will be categorized into three groups (e.g., Low, Medium, High adiposity) based on a composite of iDXA |
Contacts
CONTACTÉlisabeth Nguyen, DtP, M.Sc
CONTACTValérie Parent
PRINCIPAL_INVESTIGATORSarah Béland-Bonenfant, M.D. Ph.D
Institut de recherches cliniques de Montréal
PRINCIPAL_INVESTIGATORRémi Rabasa-Lhoret, M.D. Ph.D
Institut de recherches cliniques de Montréal
Outcome results
None listed