Prevalence and Risk Factors of Metabolic-Associated Hepatic Steatosis in Individuals Living With Type 1 Diabetes
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Conditions studied: Type 1 Diabetes, Liver Steatoses, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Liver Fibrosis, Latent Autoimmune Diabetes in Adult (LADA)
In brief
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.
Key facts
- Study ID
- NCT07475962
- Run by
- Institut de Recherches Cliniques de Montreal
- People needed
- 100
- Starts
- 2026-04-01
- Expected to finish
- 2027-05-30
- Last updated by the study team
- 2026-03-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Full record on ClinicalTrials.gov
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