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

Prevalence of Metabolic Associated Fatty Liver Disease in Patients With Type 2 Diabetes in Jiangsu Province of China: a Prospective, Multicenter, Real-world Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05597709
Enrollment
2900
Registered
2022-10-28
Start date
2022-07-01
Completion date
2027-06-01
Last updated
2022-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Type 2 diabetes mellitus, Metabolic associated fatty liver disease, ultrasound attenuation parameter

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.

Interventions

PROCEDUREUltrasound 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

Sponsors

Zhongda Hospital
CollaboratorOTHER
Suzhou Municipal Hospital
CollaboratorOTHER
Suzhou Fifth People's Hospital
CollaboratorUNKNOWN
Xuzhou Mining Group General Hospital
CollaboratorUNKNOWN
Nantong First People's Hospital
CollaboratorOTHER
Changzhou Second People's Hospital
CollaboratorUNKNOWN
Huaian Second People's Hospital
CollaboratorUNKNOWN
Huaian Hospital
CollaboratorUNKNOWN
Taizhou Jiangyan Traditional Chinese Medicine Hospital
CollaboratorUNKNOWN
Yangzhou Jiangdu People's Hospital
CollaboratorUNKNOWN
Huaian Xuyi County People's Hospital
CollaboratorUNKNOWN
Wuxi Hisky Medical Technology Co Ltd
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The proportion of patients with MAFLD in the T2DM population screened by UAP with iLivTouch12 monthsTo explore the prevalence and clinical characteristics of MAFLD in patients with T2DM
Correlation between UAP and insulin resistance12 monthsTo explore the correlation between UAP and insulin resistance in patients with T2DM
Analysis of risk factors for clinical outcomes in patients with T2DM5 yearsTo analyze risk factors affecting clinical outcomes in patients with T2DM

Countries

China

Contacts

Primary ContactLing Li, Professor
lingli2022@hotmail.com+8613951606816
Backup ContactWeixia Sun
weixia19960914@163.com+8615562596360

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026