Multicenter Study on Early Arterial Changes in Prediabetic Patients Evaluated by Ultra-High-Frequency Ultrasound

Sponsor
Chunyan Ma
Study ID
NCT07271745
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Prediabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Accepted

Study Details

Ultra-high frequency ultrasound technology (20-100 MHz) can clearly distinguish the arterial intima and media layers, and can simultaneously meet the needs of examining the carotid artery and peripheral arteries, enabling earlier and more accurate detection of vascular damage in pre-diabetic individuals. Therefore, this study aims to establish the normal values of arterial intima and media thickness measured by ultra-high frequency ultrasound in healthy Chinese adults, providing quantitative reference for the early diagnosis, severity assessment, and efficacy observation of arterial diseases. Meanwhile, by applying ultra-high frequency ultrasound, this study intends to clarify the changes in arterial intima and media thickness in pre-diabetic populations and explore the influencing factors, so as to provide reference for the early prevention, diagnosis, and treatment of pre-diabetes and cardiovascular complications.

Key Dates

First listed
Dec 9, 2025
Start date
Dec 15, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
1,740 participants (estimated)

Arms

  • Arm: Healthy control group
    According to the criteria for establishing normal values, a total of 1,440 healthy Chinese adults were enrolled, stratified by gender and age, with 720 males and 720 females.
  • Arm: Prediabetic Patients group
    Patients meeting the 2019 WHO diagnostic criteria for prediabetes: impaired fasting glucose (venous plasma glucose ≥6.1 mmol/L, \<7.0 mmol/L, and \<7.8 mmol/L after glucose loading) and/or impaired glucose tolerance (venous plasma glucose \<7.0 mmol/L, and ≥7.8 mmol/L, \<11.1 mmol/L after glucose loading). A total of 300 prediabetic patients were included.

Primary Outcome Measure

Measure the thickness of the arterial intima (mm), media (mm), and intima-media (mm) respectively [ Time Frame: 1 day ]

Central Contacts

  • Chunyan Ma, Ph.D.
    86+13998816448
    [email protected]
  • Guangyuan Li, PhD candidate
    86-15140191401
    604221697@@qq.com

Related Studies