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

NCT ID: NCT05597709

Last Updated: 2022-10-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 2900 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2027-06-01

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.

Conditions

Type 2 Diabetes Mellitus in Remission; Metabolic Associated Fatty Liver Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients who diagnosed as T2DM

Diagnosed as T2DM according to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes

Ultrasound attenuation parameter measurement, fasting blood glucose and fasting insulin determination

Intervention Type: PROCEDURE

Eligible participants will receive ultrasound attenuation parameter with iLivTouch, fasting blood glucose and fasting insulin determination

Interventions

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongda Hospital

OTHER

Sponsor Role: collaborator

Suzhou Municipal Hospital

OTHER

Sponsor Role: collaborator

Suzhou Fifth People's Hospital

UNKNOWN

Sponsor Role: collaborator

Xuzhou Mining Group General Hospital

UNKNOWN

Sponsor Role: collaborator

Nantong First People's Hospital

OTHER

Sponsor Role: collaborator

Changzhou Second People's Hospital

UNKNOWN

Sponsor Role: collaborator

Huaian Second People's Hospital

UNKNOWN

Sponsor Role: collaborator

Huaian Hospital

UNKNOWN

Sponsor Role: collaborator

Taizhou Jiangyan Traditional Chinese Medicine Hospital

UNKNOWN

Sponsor Role: collaborator

Yangzhou Jiangdu People's Hospital

UNKNOWN

Sponsor Role: collaborator

Huaian Xuyi County People's Hospital

UNKNOWN

Sponsor Role: collaborator

Wuxi Hisky Medical Technology Co Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ling Li, Professor

Role: PRINCIPAL_INVESTIGATOR

Zhongda Hospital

Locations

Zhongda Hospital, Medical School, Southeast University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ling Li, Professor

Role: CONTACT

lingli2022@hotmail.com

+8613951606816

Weixia Sun

Role: CONTACT

weixia19960914@163.com

+8615562596360

Facility Contacts

Ling Li, Professor

Role: primary

lingli2022@hotmail.com

+8613951606816

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Other Identifiers

MAFLD

Identifier Type: -

Identifier Source: org_study_id