Type 1 DiabetesSTEA-DT1NCT07475962
Prevalence and Risk Factors of Metabolic-Associated Hepatic Steatosis in Individuals Living With Type 1 Diabetes
An observational study of Type 1 Diabetes and Liver Steatoses, run by Institut de Recherches Cliniques de Montreal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Liver Steatoses, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
- What is being tested?
- Adiposity and BMI Classification
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 30 May 2027
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Valérie Parent contact
About this study
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:
Read more
- What is the prevalence and severity of liver steatosis and fibrosis among people living with type 1 diabetes in Québec?
- 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.
- Conditions
- Type 1 Diabetes, Liver Steatoses, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Liver Fibrosis, Latent Autoimmune Diabetes in Adult (LADA)
- Being tested
- Adiposity and BMI Classification
- Keywords
- MASLD, Liver steatosis, Liver fibrosis, LADA, Body composition, Type 1 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Fatty Liver, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adiposity and BMI ClassificationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Adults with type 1 diabetes or LADA without increased adiposity and without any BMI-based criterion. Receives: Other: Adiposity and BMI Classification | |
| Overweight group | Adults with T1D or LADA with a BMI between 25.0 and 29.9 kg/m² combined with increased adiposity Receives: Other: Adiposity and BMI Classification | |
| Obesity Group | Adults with T1D or LADA with a BMI of 30 kg/m² or higher combined with increased adiposity. Receives: Other: Adiposity and BMI Classification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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%).
Measured: Baseline (Day 1 / Single Study Visit)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: Baseline (Day 1 / Single Study Visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Beland Bonenfant, Institut de Recherches Cliniques de Montreal
- Investigators
- Sarah Béland-Bonenfant, M.D. Ph.D, Principal investigator, Institut de Recherches Cliniques de MontrealRémi Rabasa-Lhoret, M.D. Ph.D, Principal investigator, Institut de Recherches Cliniques de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475962
- Sponsor's protocol ID
- 2026-1350
- Acronym
- STEA-DT1
- Status last verified
- Feb 2026
- First submitted
- 3 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39672250European 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.
PubMed 38851997Lalanne-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.
PubMed 39193662
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors of Metabolic-Associated Hepatic Steatosis in Individuals Living With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07475962
- Acronym / sponsor ID
- STEA-DT1 / 2026-1350
- Conditions
- Type 1 Diabetes, Liver Steatoses, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Liver Fibrosis, Latent Autoimmune Diabetes in Adult (LADA)
- Keywords
- MASLD, Liver steatosis, Liver fibrosis, LADA, Body composition, Type 1 diabetes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the prevalence and severity of liver steatosis and fibrosis among people living with type 1 diabetes in Québec?
- 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: Adiposity and BMI ClassificationAdults with type 1 diabetes or LADA without increased adiposity and without any BMI-based criterion. |
| Overweight group | – | Other: Adiposity and BMI ClassificationAdults 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 ClassificationAdults with T1D or LADA with a BMI of 30 kg/m² or higher combined with increased adiposity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adiposity and BMI ClassificationParticipants 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). | Other | Control group, Obesity Group, Overweight group |
Primary outcome
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)
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%).
3 secondary outcomes
Anthropometric Assessment: Body mass Index (BMI)
Time frame: Baseline (Day 1 / Single Study Visit)
Anthropometric Assessment: Waist circumference
Time frame: Baseline (Day 1 / Single Study Visit)
Adiposity-Based Subgroup Classification
Time frame: Baseline (Day 1 / Single Study Visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Background: PubMed 39672250Souza 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.
- Background: PubMed 38851997European 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.
- Background: PubMed 39193662Lalanne-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valérie Parent contact
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
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and Liver Steatoses, run by Institut de Recherches Cliniques de Montreal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Élisabeth Nguyen, DtP, M.Sc ((514) 987-5617, elisabeth.nguyen@ircm.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of liver fibrosis using FibroScan (time frame: Baseline (Day 1 / Single Study Visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07475962, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.