Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Adults with type 1 diabetes or LADA without increased adiposity and without any BMI-based criterion. |
| |
| Overweight group | Adults with T1D or LADA with a BMI between 25.0 and 29.9 kg/m² combined with increased adiposity |
| |
| Obesity Group | Adults with T1D or LADA with a BMI of 30 kg/m² or higher combined with increased adiposity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adiposity and BMI Classification | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline (Day 1 / Single Study Visit) |
| Degree of liver steatosis assessment | 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%). | Baseline (Day 1 / Single Study Visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometric Assessment: Body mass Index (BMI) | Body mass index (BMI: kg/m^2) will be calculated using weight (kg) and height (cm) to compare FibroScan results across predefined subgroups. | Baseline (Day 1 / Single Study Visit) |
| Anthropometric Assessment: Waist circumference |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Use Disorders Identification Test (AUDIT) Score | Total score from the 10-item AUDIT questionnaire to assess alcohol consumption. Range: 0 to 40. A higher score indicates a greater risk of hazardous and harmful alcohol use, as well as potential alcohol dependence (A score of 8 or more is typically considered the threshold for hazardous drinking). | Baseline (Day 1 / Single Study Visit) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The study population will consist of 100 adults (aged 18 years and older) living with type 1 diabetes or LADA for at least one year.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Élisabeth Nguyen, DtP, M.Sc | Contact | (514) 987-5617 | elisabeth.nguyen@ircm.qc.ca | |
| Valérie Parent | Contact | valerie.parent@ircm.qc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Sarah Béland-Bonenfant, M.D. Ph.D | Institut de Recherches Cliniques de Montreal | Principal Investigator |
| Rémi Rabasa-Lhoret, M.D. Ph.D | Institut de Recherches Cliniques de Montreal | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39672250 | Background | Souza M, Al-Sharif L, Khalil SM, Villela-Nogueira CA, Mantovani A. Global Epidemiology and Characteristics of Metabolic Dysfunction-associated Steatotic Liver Disease in Type 1 Diabetes Mellitus: An Updated Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2025 Jul;23(8):1308-1319.e17. doi: 10.1016/j.cgh.2024.09.038. Epub 2024 Dec 11. | |
| 38851997 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Waist circumference and hip circumference (cm) will be used to compare FibroScan results across predefined subgroups. |
| Baseline (Day 1 / Single Study Visit) |
| Adiposity-Based Subgroup Classification | Participants will be categorized into three groups (e.g., Low, Medium, High adiposity) based on a composite of iDXA | Baseline (Day 1 / Single Study Visit) |
| Physical Activity Level (IPAQ) | Total physical activity expressed as Metabolic Equivalent of Task (MET)-minutes per week. A higher score (higher MET-minutes/week) indicates a higher level of physical activity. | Baseline (Day 1 / Single Study Visit) |
| Eating Behavior (Three-Factor Eating Questionnaire: TFEQ) | The TFEQ-R18 is an 18-item validated tool used to assess three domains of eating behavior: Cognitive Restraint, Uncontrolled Eating, and Emotional Eating. Raw scores are transformed to a 0-100 scale. For all sub-scales, higher scores indicate a greater presence of that specific eating behavior (e.g., higher emotional eating or higher restraint). | Baseline (Day 1 / Single Study Visit) |
| Dietary Intake (RxFood Diary) | Average daily caloric intake calculated over 3 days | Baseline (Day 1 / Single Study Visit) |
| European Association for the Study of the Liver (EASL); European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO). EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). J Hepatol. 2024 Sep;81(3):492-542. doi: 10.1016/j.jhep.2024.04.031. Epub 2024 Jun 7. |
| 39193662 | Background | Lalanne-Mistrih ML, Bonhoure A, Messier V, Boudreau V, Lebbar M, Talbo MK, Sun CJ, Bandini A, Secours L, Calderon V, Grou C, Tressieres B, Brazeau AS, Rabasa-Lhoret R. Overweight and Obesity in People Living With Type 1 Diabetes: A Cross-Sectional Analysis of the BETTER Registry. Diabetes Metab Res Rev. 2024 Sep;40(6):e3837. doi: 10.1002/dmrr.3837. |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D005234 | Fatty Liver |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D050154 | Adiposity |
| ID | Term |
|---|---|
| D050218 | Body Fat Distribution |
| D001837 | Body Weights and Measures |
| D001824 | Body Constitution |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D001823 | Body Composition |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D008660 | Metabolism |
| D010829 | Physiological Phenomena |
Not provided
Not provided