Prevalence of MAFLD in Patients With Type 2 Diabetes in Jiangsu Province of China

Metabolic Associated Fatty Liver Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05597709
• Other study ID #: MAFLD
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: June 1, 2027

Study information

• Verified date: October 2022
• Source: Wuxi Hisky Medical Technology Co Ltd
• Contact: Ling Li, Professor
• Phone: +8613951606816
• Email: lingli2022[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2900
• Est. completion date: June 1, 2027
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Fatty Liver
• Liver Diseases
• Metabolic Associated Fatty Liver Disease
• Non-alcoholic Fatty Liver Disease

Intervention

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

Locations

Country	Name	City	State
China	Zhongda Hospital, Medical School, Southeast University	Nanjing	Jiangsu

Sponsors (12)

Lead Sponsor

Collaborator

Wuxi Hisky Medical Technology Co Ltd

Changzhou Second People's Hospital, Huaian Hospital, Huaian Second People's Hospital, Huaian Xuyi County People's Hospital, Nantong First People's Hospital, Suzhou Fifth People's Hospital, Suzhou Municipal Hospital, Taizhou Jiangyan Traditional Chinese Medicine Hospital, Xuzhou Mining Group General Hospital, Yangzhou Jiangdu People's Hospital, Zhongda Hospital, Medical School, Southeast University

Country where clinical trial is conducted

China, 

References & Publications (27)

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Primary	Correlation between UAP and insulin resistance	To explore the correlation between UAP and insulin resistance in patients with T2DM	12 months
Primary	Analysis of risk factors for clinical outcomes in patients with T2DM	To analyze risk factors affecting clinical outcomes in patients with T2DM	5 years