Not Yet RecruitingNot Applicable

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

100 participantsStarted 2026-04-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of liver fibrosis using FibroScan

Timeframe: Baseline (Day 1 / Single Study Visit)

Degree of liver steatosis assessment

Timeframe: Baseline (Day 1 / Single Study Visit)

Trial details

NCT IDNCT07475962

SponsorInstitut de Recherches Cliniques de Montreal

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-04-01

Contact for this trial

Élisabeth Nguyen, DtP, M.Sc

(514) 987-5617 elisabeth.nguyen@ircm.qc.ca

View on ClinicalTrials.gov More Type 1 Diabetes trials