An observational study in Type 1 Diabetes, Liver Steatoses and MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, sponsored by Institut de Recherches Cliniques de Montreal. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by Institut de Recherches Cliniques de Montreal · Observational
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:
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's planned enrollment of 100 is below the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Institut de Recherches Cliniques de Montreal is the lead sponsor of 61 studies on the registry; 11 are open to participants now.
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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.
Exclusion Criteria:
Adults with type 1 diabetes or LADA without increased adiposity and without any BMI-based criterion.
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
Other: Adiposity and BMI Classification
Adults with T1D or LADA with a BMI of 30 kg/m² or higher combined with increased adiposity.
Other: Adiposity 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).
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)
Time frame: 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%).
Time frame: Baseline (Day 1 / Single Study Visit)
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.
Time frame: Baseline (Day 1 / Single Study Visit)
Anthropometric Assessment: Waist circumference
Waist circumference and hip circumference (cm) will be used to compare FibroScan results across predefined subgroups.
Time frame: 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
Time frame: Baseline (Day 1 / Single Study Visit)
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).
Time frame: 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.
Time frame: 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).
Time frame: Baseline (Day 1 / Single Study Visit)
Dietary Intake (RxFood Diary)
Average daily caloric intake calculated over 3 days
Time frame: Baseline (Day 1 / Single Study Visit)
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Institut de Recherches Cliniques de Montreal