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All trials for Type 1 Diabetes All trials for Liver Steatoses All trials of Adiposity and BMI Classification
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Control group | | Other: Adiposity and BMI Classification | Adults with type 1 diabetes or LADA without increased adiposity and without any BMI-based criterion. |
| Overweight group | | Other: Adiposity and BMI Classification | Adults with T1D or LADA with a BMI between 25.0 and 29.9 kg/m² combined with increased adiposity |
| Obesity Group | | Other: Adiposity and BMI Classification | Adults with T1D or LADA with a BMI of 30 kg/m² or higher combined with increased adiposity. |
- 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).
+Outcome measures
Primary outcomes
- 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 outcomes
- 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
Other outcomes
- Alcohol Use Disorders Identification Test (AUDIT) Score [Baseline (Day 1 / Single Study Visit)]: 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).
- Physical Activity Level (IPAQ) [Baseline (Day 1 / Single Study Visit)]: 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.
- Eating Behavior (Three-Factor Eating Questionnaire: TFEQ) [Baseline (Day 1 / Single Study Visit)]: 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).
- Dietary Intake (RxFood Diary) [Baseline (Day 1 / Single Study Visit)]: Average daily caloric intake calculated over 3 days
+Eligibility
Sex: All, ages: 18 Years to any
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.
+Publications
- 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. PMID 39672250
- 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. PMID 38851997
- 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. PMID 39193662
+Investigators
- Sarah Béland-Bonenfant, M.D. Ph.D, Principal investigator, Institut de Recherches Cliniques de Montreal
- Rémi Rabasa-Lhoret, M.D. Ph.D, Principal investigator, Institut de Recherches Cliniques de Montreal