An observational study in Type 2 Diabetes Mellitus in Remission and Metabolic Associated Fatty Liver Disease, sponsored by Wuxi Hisky Medical Technology Co Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-28.
Sponsored by Wuxi Hisky Medical Technology Co Ltd · Observational
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.
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.
2,081 studies on the registry are indexed under Liver Diseases; 389 are open to participants now.
This study's planned enrollment of 2,900 is above the median of 167 across 681 observational studies indexed under Liver Diseases.
Browse Liver Diseases studies →Wuxi Hisky Medical Technology Co Ltd is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Patients with T2DM
Exclusion Criteria:
Diagnosed as T2DM according to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes
Procedure: Ultrasound attenuation parameter measurement, fasting blood glucose and fasting insulin determination
Eligible participants will receive ultrasound attenuation parameter with iLivTouch, fasting blood glucose and fasting insulin determination
The proportion of patients with MAFLD in the T2DM population screened by UAP with iLivTouch
To explore the prevalence and clinical characteristics of MAFLD in patients with T2DM
Time frame: 12 months
Correlation between UAP and insulin resistance
To explore the correlation between UAP and insulin resistance in patients with T2DM
Time frame: 12 months
Analysis of risk factors for clinical outcomes in patients with T2DM
To analyze risk factors affecting clinical outcomes in patients with T2DM
Time frame: 5 years
Plan to share: No
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