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NCT Number: NCT05597709

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus in Remission Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Associated Fatty Liver Disease Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongda Hospital, Medical School, Southeast University

Nanjing, Jiangsu, China

Location status: Recruiting

Location contact

Ling Li, Professor

CONTACT

[email protected]

+8613951606816

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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

Primary outcomes

  1. The proportion of patients with MAFLD in the T2DM population screened by UAP with iLivTouch

    Time frame: 12 months

    To explore the prevalence and clinical characteristics of MAFLD in patients with T2DM

  2. Correlation between UAP and insulin resistance

    Time frame: 12 months

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

  3. Analysis of risk factors for clinical outcomes in patients with T2DM

    Time frame: 5 years

    To analyze risk factors affecting clinical outcomes in patients with T2DM

Study contacts

Contact information is provided by the study sponsor or research team.

Ling Li, Professor

CONTACT

[email protected]

+8613951606816

Weixia Sun

CONTACT

[email protected]

+8615562596360

Sponsors and collaborators

Lead sponsor

Wuxi Hisky Medical Technology Co Ltd

Industry

Collaborators

  • 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

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2027
First posted
Oct 28, 2022
Registry last updated
Oct 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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