Prevalence and Risk Factors of Metabolic-Associated Hepatic Steatosis in Individuals Living With Type 1 Diabetes (STEA-DT1)

March 19, 2026 updated by: Sarah Beland Bonenfant, Institut de Recherches Cliniques de Montreal

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
Adults with type 1 diabetes or LADA without increased adiposity and without any BMI-based criterion.
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).
Obesity Group
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).
Overweight group
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of liver fibrosis using FibroScan
Time Frame: 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)
Baseline (Day 1 / Single Study Visit)
Degree of liver steatosis assessment
Time Frame: 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%).
Baseline (Day 1 / Single Study Visit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometric Assessment: Body mass Index (BMI)
Time Frame: 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.
Baseline (Day 1 / Single Study Visit)
Anthropometric Assessment: Waist circumference
Time Frame: Baseline (Day 1 / Single Study Visit)
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
Time Frame: 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
Baseline (Day 1 / Single Study Visit)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary Intake (RxFood Diary)
Time Frame: Baseline (Day 1 / Single Study Visit)
Average daily caloric intake calculated over 3 days
Baseline (Day 1 / Single Study Visit)
Alcohol Use Disorders Identification Test (AUDIT) Score
Time Frame: 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).
Baseline (Day 1 / Single Study Visit)
Physical Activity Level (IPAQ)
Time Frame: 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.
Baseline (Day 1 / Single Study Visit)
Eating Behavior (Three-Factor Eating Questionnaire: TFEQ)
Time Frame: 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).
Baseline (Day 1 / Single Study Visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Recherches Cliniques de Montreal

Investigators

  • Principal Investigator: Rémi Rabasa-Lhoret, M.D. Ph.D, Institut de recherches cliniques de Montreal
  • Principal Investigator: Sarah Béland-Bonenfant, M.D. Ph.D, Institut de recherches cliniques de Montreal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 30, 2027

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-1350

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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