Actively Recruiting
Led by Wuxi Hisky Medical Technology Co Ltd · Updated on 2022-10-28
2900
Participants Needed
1
Research Sites
208 weeks
Total Duration
W
Wuxi Hisky Medical Technology Co Ltd
Lead Sponsor
Z
Zhongda Hospital
Collaborating Sponsor
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
Prevalence of MAFLD in Patients With Type 2 Diabetes in Jiangsu Province of China
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
Zhongda Hospital, Medical School, Southeast University
Nanjing, Jiangsu, China
Actively Recruiting
L
Ling Li, Professor
W
Weixia Sun
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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