Study of Metabolic Associated Fatty Liver Disease in Adults With Type 2 Diabetes in Jiangsu Province, China
A Real-World, Multicenter, 5-Year Follow-Up Study
Led by Wuxi Hisky Medical Technology Co Ltd · Updated on 2022-10-28
2900
Participants Needed
1
Research Sites
208 weeks
Total Duration
AI-Summary
What this Trial Is About
This research investigates the prevalence and characteristics of metabolic associated fatty liver disease MAFLD in patients with type 2 diabetes mellitus T2DM in Jiangsu Province, China. It aims to understand the relationship between ultrasound attenuation parameters UAP used to assess liver fat and insulin resistance in T2DM patients. The study follows participants for up to five years to analyze clinical outcomes and risk factors related to T2DM and MAFLD progression.
Participants diagnosed with T2DM according to Chinese guidelines will undergo ultrasound attenuation measurement using the iLivTouch device, along with fasting blood glucose and insulin tests. These procedures will help assess liver fat content and insulin resistance. The study includes multiple follow-up visits at 3, 6, 12, 36, 48, and 60 months to monitor participants health status over time.
During the study, participants will be evaluated using ultrasound and blood tests to track liver fat and insulin resistance. Researchers will analyze the proportion of T2DM patients with MAFLD and examine how these factors relate to clinical outcomes over five years. The study aims to identify risk factors influencing disease progression, with all assessments occurring in a real-world, observational setting.
CONDITIONS
Brief Title
Prevalence of MAFLD in Patients With Type 2 Diabetes in Jiangsu Province of China
Research Team
L
Ling Li, Professor
W
Weixia Sun
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Diagnosed with type 2 diabetes mellitus according to Chinese guidelines
Ultrasound attenuation parameters measured using iLivTouch
Willing and able to provide written informed consent
You will not qualify if you...
Having other types of diabetes
Unable to attend regular follow-up visits
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 12 months
Participants undergo ultrasound attenuation parameter measurement along with fasting blood glucose and insulin tests to assess liver fat content and insulin resistance.
Multiple assessments over 12 months
Long-term Monitoring
Duration - Up to 5 years
Participants are followed for up to 5 years to observe clinical outcomes and analyze risk factors related to type 2 diabetes and MAFLD.
Follow-up visits at 3 months, 6 months, 12 months, 36 months, 48 months, and 60 months
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Study of Metabolic Associated Fatty Liver Disease in Adults With Type 2 Diabetes in Jiangsu Province, China
A Real-World, Multicenter, 5-Year Follow-Up Study
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Published Research Related To This Trial
Diagnostic Performance of FibroTouch Ultrasound Attenuation Parameter and Liver Stiffness Measurement in Assessing Hepatic Steatosis and Fibrosis in Patients With Nonalcoholic Fatty Liver Disease.