Prevalence and Risk Factors of Metabolic-Associated Hepatic Steatosis in Individuals Living With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Assessment of liver fibrosis using FibroScan
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Control group
Adults with type 1 diabetes or LADA without increased adiposity and without any BMI-based criterion.
干预措施: Adiposity and BMI Classification (Other)
Obesity Group
Adults with T1D or LADA with a BMI of 30 kg/m² or higher combined with increased adiposity.
干预措施: Adiposity and BMI Classification (Other)
结局指标
主要结局
Assessment of liver fibrosis using FibroScan
时间窗: 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
时间窗: 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%).
次要结局
- Adiposity-Based Subgroup Classification(Baseline (Day 1 / Single Study Visit))
- Anthropometric Assessment: Body mass Index (BMI)(Baseline (Day 1 / Single Study Visit))
- Anthropometric Assessment: Waist circumference(Baseline (Day 1 / Single Study Visit))
研究者
Sarah Beland Bonenfant
Clinical Professor
Institut de Recherches Cliniques de Montreal