Prevalence of Metabolic Associated Fatty Liver Disease in Patients With Type 2 Diabetes in Jiangsu Province of China: a Prospective, Multicenter, Real-world Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,900
- 试验地点
- 1
- 主要终点
- The proportion of patients with MAFLD in the T2DM population screened by UAP with iLivTouch
研究概览
简要总结
In 2019, the number of patients with diabetes was about 463 million in the world, accounting for 8.3% of the total population, and it is expected to rise to 578 million (9.2%) by 2030 and 700 million (9.6%) by 2045. According to the WHO diagnostic criteria, the prevalence of diabetes among adults in China from 2015 to 2017 was 11.2%, of which over 90% were type 2 diabetes mellitus (T2DM). The global prevalence of non-alcoholic fatty liver disease (NAFLD) is also very high, which was approximately 25% in 2016. The prevalence of NAFLD may continue to rise. NAFLD is often accompanied by clinical manifestations of metabolic syndrome, such as obesity, T2DM, hyperlipidemia and hypertension.
详细描述
The presence of NAFLD not only increases the risk of T2DM, but also accelerates the process of various diabetes-related organ damage in patients with T2DM. Similarly, T2DM also increases the risk of NAFLD. However, in patients with T2DM, there are few reports on the correlation between ultrasound attenuation parameters for non-invasive assessment of liver fat content and insulin resistance. In addition, T2DM may be the most important predictor of adverse clinical outcomes in NAFLD patients. T2DM is an important predictor of NAFLD patients progressing to compensated advanced chronic liver disease (cACLD), and even cirrhotic portal hypertension and other end-stage liver diseases.
In February 2020, international experts suggested NAFLD to be renamed metabolic associated fatty liver disease (MAFLD). In April of the same year, the Journal of Hepatology released a new definition and diagnosis of MAFLD with the criteria based on histological (liver biopsy), imaging, or blood biomarker indicating the presence of hepatic fat accumulation (hepatocyte steatosis), in combination with one of the following 3 conditions: overweight/obesity, type 2 diabetes and metabolic dysfunction. The new diagnostic criteria are based on underlying metabolic abnormalities and recognize that MAFLD often coexists with other diseases.
Therefore, this study aims to investigate the prevalence and clinical characteristics of MAFLD in patients with T2DM, as well as the correlation between UAP and insulin resistance in T2DM. Patients will be followed up to 5 years for the clinical outcomes at 3months, 6 months, 12 months, 36 months, 48 months and 60 months respectively and the risk factors affecting the clinical outcomes of patients with T2DM will be analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosed as T2DM according to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes
- •UAP were measured based on iLivTouch
- •Willing to attend this study and able to provide the written informed consent.
排除标准
- •Other types of diabetes
- •Patients unable to receive regular follow-up
结局指标
主要结局
The proportion of patients with MAFLD in the T2DM population screened by UAP with iLivTouch
时间窗: 12 months
To explore the prevalence and clinical characteristics of MAFLD in patients with T2DM
Correlation between UAP and insulin resistance
时间窗: 12 months
To explore the correlation between UAP and insulin resistance in patients with T2DM
Analysis of risk factors for clinical outcomes in patients with T2DM
时间窗: 5 years
To analyze risk factors affecting clinical outcomes in patients with T2DM
次要结局
未报告次要终点