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

NCT05597709 | Recruiting DMC

• 1 other identifier: MAFLD
• Study Type: observational
• Target: 2,900
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

• Correlation between UAP and insulin resistance

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

  12 months

• Analysis of risk factors for clinical outcomes in patients with T2DM

  To analyze risk factors affecting clinical outcomes in patients with T2DM

  5 years

Study Arms (1)

Patients who diagnosed as T2DM

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

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

Interventions

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

Patients who diagnosed as T2DM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with T2DM

You may qualify if:

• 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.

You may not qualify if:

• Other types of diabetes
• Patients unable to receive regular follow-up

Sponsors & Collaborators

• Wuxi Hisky Medical Technology Co Ltd: lead
• 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

Study Sites (1)

Zhongda Hospital, Medical School, Southeast University

Nanjing, Jiangsu, China

RECRUITING

Related Publications (29)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Biospecimen including blood samples for blood glucose measurement (fasting blood glucose, glycosylated hemoglobin), fasting insulin level, biochemical examination (PLT, AST, ALT, ALP, GGT, TBIL, DBIL, TC, TG, LDL-C, HDL-C, etc.), and FIB-4(PC III, IV-C, LN, HA）.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ling Li, Professor

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ling Li, Professor

CONTACT

+8613951606816; lingli2022@hotmail.com

Weixia Sun

CONTACT

+8615562596360; weixia19960914@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 28, 2022
• Study Start: July 1, 2022
• Primary Completion: June 1, 2023
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)