Screening of Liver Fibrosis Using Blood Tests in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 722
- 试验地点
- 4
- 主要终点
- eLift and FibroMeter sensitivity for the diagnosis of advanced hepatic fibrosis
研究概览
简要总结
Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic SteatoHepatitis (NASH), are a frequent complication of type 2 diabetes and obesity. This disease has been linked with an increased morbidity and mortality, in particular cardiovascular disease and hepatic complications (cirrhosis and hepatocellular carcinoma). NAFLD is covered different liver damage in ascending order: steatosis, Non-Alcoholic SteatoHepatitis (NASH), fibrosis, and finally cirrhosis. Mostly, fibrosis has a determining role in the patient's status health. The fibrosis prevalence rate may reach up to 15 % of people with type 2 diabetes. The purpose of the study is to screen hepatic fibrosis for patient with type 2 diabetes.
To be sure of the status of the disease, the gold standard procedure remains liver biopsy. However, it's an invasive procedure and it's a challenge to perform this kind of medical procedure to every patient with NAFLD. Some alternative procedure exists, called FibroScan that gives some indication of liver fibrosis status. Unfortunately, every diabetologist hasn't this equipment in his medical office. The investigators propose to evaluate two non-invasive biological fibrosis tests, called eLIFT and FibroMeter. The results of these two diagnostic tests will be compared to FibroScan and to liver biopsy results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years old,
- •Type 2 diabetes mellitus for more than 6 months,
- •BMI > 25 kg/m2,
- •Waist circumference > 94 cm (male) or 80 cm (female).
- •Patient benefiting from a social security system.
排除标准
- •Medical follow up for liver disease,
- •Decompensated cirrhosis,
- •Health status that does not allow the participation of the patient,
- •Hospitalisation for acute complication: sepsis, infection, foot's ulcer, acute coronary syndrome,…
- •HbA1c > 11,0 %,
- •Pregnancy.
- •Patient under guardianship or curatorship or protection of justice
- •Involvement refusal.
结局指标
主要结局
eLift and FibroMeter sensitivity for the diagnosis of advanced hepatic fibrosis
时间窗: Day 0
sensitivity calculated as follows: (number of patients with advanced hepatic fibrosis and a positive test) / (number of patients with advanced hepatic fibrosis)
次要结局
- Controlled Attenuation Parameter (CAP) measurement by FibroScan(3 months)
- Patient rate with eLIFT ≥8 versus FibroMeter ≥0.22.(Day 0)
- Complication of diabetes(Day 0)
- number of advanced hepatic fibrosis diagnosed according to the FibroScan composite criterion and then liver biopsy(3 months)
- Liver hardness (kPa) measured by FibroScan(3 months)