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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWuxi Hisky Medical Technology Co Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Other types of diabetes

Patients unable to receive regular follow-up

Trial population

Patients with T2DM

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Procedure/Surgery

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

Treatment groups

2,900 Participants
are divided into 1 treatment group
Group A: Patients who diagnosed as T2DM1 intervention

Trial outcomes

Primary outcomes

1

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
2

Correlation between UAP and insulin resistance

To explore the correlation between UAP and insulin resistance in patients with T2DM

Time frame
12 months
3

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wuxi Hisky Medical Technology Co Ltd

Lead sponsor

Zhongda Hospital

Collaborator

Suzhou Municipal Hospital

Collaborator

Suzhou Fifth People's Hospital

Collaborator

Xuzhou Mining Group General Hospital

Collaborator

Nantong First People's Hospital

Collaborator

Changzhou Second People's Hospital

Collaborator

Huaian Second People's Hospital

Collaborator

Huaian Hospital

Collaborator

Taizhou Jiangyan Traditional Chinese Medicine Hospital

Collaborator

Yangzhou Jiangdu People's Hospital

Collaborator

Huaian Xuyi County People's Hospital

Collaborator