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

Обзор

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.

Вмешательства

• Другое 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).

Первичные конечные точки

• Assessment of liver fibrosis using FibroScan [Срок оценки: Baseline (Day 1 / Single Study Visit)]
• Degree of liver steatosis assessment [Срок оценки: Baseline (Day 1 / Single Study Visit)]

Вторичные конечные точки (3)

• Anthropometric Assessment: Body mass Index (BMI) [Срок оценки: Baseline (Day 1 / Single Study Visit)]
• Anthropometric Assessment: Waist circumference [Срок оценки: Baseline (Day 1 / Single Study Visit)]
• Adiposity-Based Subgroup Classification [Срок оценки: Baseline (Day 1 / Single Study Visit)]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 39672250
• European 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. PMID 38851997
• Lalanne-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. PMID 39193662

Идентификаторы

NCT: NCT07475962 · 2026-1350

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗