Clinical trial NCT05597709: Prevalence of MAFLD in Patients With Type 2 Diabetes in Jiangsu Province of China
Official title: Prevalence of Metabolic Associated Fatty Liver Disease in Patients With Type 2 Diabetes in Jiangsu Province of China: a Prospective, Multicenter, Real-world Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes Mellitus in Remission
Metabolic Associated Fatty Liver Disease
Keywords: Type 2 diabetes mellitus
Metabolic associated fatty liver disease
ultrasound attenuation parameter
Lead sponsor: Wuxi Hisky Medical Technology Co Ltd
Sponsor class: INDUSTRY
Collaborators: name: Zhongda Hospital
name: Suzhou Municipal Hospital
name: Suzhou Fifth People's Hospital
name: Xuzhou Mining Group General Hospital
name: Nantong First People's Hospital
name: Changzhou Second People's Hospital
name: Huaian Second People's Hospital
name: Huaian Hospital
name: Taizhou Jiangyan Traditional Chinese Medicine Hospital
name: Yangzhou Jiangdu People's Hospital
name: Huaian Xuyi County People's Hospital
First posted: 2022-10-28
Enrollment: 2900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with T2DM

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Other types of diabetes
* Patients unable to receive regular follow-up

Primary outcomes:
measure: The proportion of patients with MAFLD in the T2DM population screened by UAP with iLivTouch
timeFrame: 12 months
measure: Correlation between UAP and insulin resistance
timeFrame: 12 months
measure: Analysis of risk factors for clinical outcomes in patients with T2DM
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital, Medical School, Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Ling Li, Professor
role: PRINCIPAL_INVESTIGATOR
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