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

NCT ID: NCT07271745

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1740 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2026-12-31

Brief Summary

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.

Detailed Description

The arterial wall consists of the intima, media, and adventitia from inside to outside. Among them, intima-media thickness (IMT) is an important criterion for reflecting subclinical arteriosclerosis. However, this composite index has certain limitations. The pathological changes of atherosclerosis mainly occur in the intima, while hypertension, diabetes, etc., mainly affect the media. Therefore, measuring the thickness of the arterial intima and media separately can reflect the degree of vascular lesions in different diseases earlier and more accurately than IMT, which is of great clinical significance. However, there are currently no normal reference values for the thickness of the arterial intima and media.

Diabetes is one of the fastest-growing global public health events in the 21st century, with its prevalence and mortality rate ranking among the top of various diseases. Diabetes is also one of the diseases with the most complications, among which cardiovascular complications cause the greatest harm to patients and have become the leading cause of death in such patients. The vast majority of patients go through a pre-diabetic stage before developing clinically diagnosed diabetes. Epidemiological survey results show that the number of patients in the pre-diabetic stage is much larger than that of diabetic patients. In addition, before diabetes is diagnosed, hyperglycemia may have already caused vascular damage, first leading to thickening and calcification of the arterial media. Studies have shown that the prevalence of vascular calcification in pre-diabetic patients is much higher than that in non-diabetic patients. Early detection of medial vascular calcification is of great clinical value for evaluating vascular changes in pre-diabetes and thus enabling early prevention. However, there is a lack of relevant studies confirming the vascular lesions in pre-diabetes.

In the past, the ultrasound probes used for clinical examination of the carotid artery and peripheral arteries were mainly 5-10 MHz, with a resolution of 200-400 μm, which cannot clearly display the fine structure of the arterial wall, making it difficult to measure the intima or media alone. With the development of modern medical technology, the emergence of ultra-high frequency ultrasound (20-100 MHz) can clearly distinguish the arterial intima and media, and can simultaneously meet the needs of examining the carotid artery and peripheral arteries. It is expected to reflect vascular lesions caused by different diseases more sensitively and accurately, providing a new and beneficial tool for clinical observation of arterial structure.

In recent years, the ultra-high frequency ultrasound technology (20-100 MHz) has emerged, which can clearly distinguish the arterial intima and media, 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-diabetes. Therefore, our center has initiated this multi-center clinical research project, joining hands with multiple ultrasound centers across the country, aiming 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, degree assessment, and efficacy observation of arterial diseases. At the same time, it aims to use ultra-high frequency ultrasound to clarify the changes in arterial intima and media thickness in pre-diabetic populations, explore the influencing factors, and provide reference for the early prevention, diagnosis, and treatment of pre-diabetes and cardiovascular complications.

Conditions

Prediabetes

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Impaired fasting glucose (venous plasma glucose ≥6.1 mmol/L, <7.0 mmol/L, and <7.8 mmol/L 2 hours after glucose loading); and/or Impaired glucose tolerance (venous plasma glucose <7.0 mmol/L, and ≥7.8 mmol/L, <11.1 mmol/L 2 hours after glucose loading).
• Age ≥ 18 years old;
• Normal blood pressure (139-90/89-60 mmHg);
• Body mass index (BMI) < 30 kg/m²;
• Normal results in routine blood tests, fasting blood glucose, lipid profile, liver and kidney function tests, and electrocardiogram (ECG);
• No history of cardiovascular diseases, diabetes, rheumatic connective tissue diseases, or severe liver/kidney dysfunction;
• No history of acrocyanosis, no discomfort under cold stimulation, and no previous Raynaud's phenomenon in any part of the body;
• No history of taking medications that affect the cardiovascular system.

Exclusion Criteria

• Patients with hypertension, diabetes mellitus, hyperthyroidism, arrhythmia, etc.
• Patients with connective tissue diseases such as systemic lupus erythematosus, polymyositis, rheumatoid arthritis, etc.
• History of blood diseases, severe infections, or other systemic diseases.
• Administration of vasoactive drugs within the past month.
• Peripheral vascular diseases with arterial occlusion that prevents detection of blood flow signals.
• Inability to cooperate with the examination.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Henan Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role: collaborator

Chunyan Ma

OTHER

Sponsor Role: lead

Responsible Party

Chunyan Ma

Chief of Cardiovascular Ultrasound

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Chunyan Ma, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

First Hospital of China Medical University

Locations

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangxi University of Chinese Medicine

Nanning, Guangxi, China

The First Affiliated Hospital of Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, China

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

The Second Hospital of Heilongjiang Province

Harbin, Heilongjiang, China

Jiamusi Central Hospital, Heilongjiang Province

Jiamusi, Heilongjiang, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

China-Japan Union Hospital of Jilin University

Changchun, Jinlin, China

The First Hospital of Jilin University

Changchun, Jinlin, China

Anshan Central Hospital

Anshan, Liaoning, China

Chaoyang Central Hospital

Chaoyang, Liaoning, China

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Shenyang, Liaoning, China

Tongliao People's Hospital of Inner Mongolia Autonomous Region

Tongliao, Neimenggu, China

Qilu Hospital (Qingdao Branch) of Shandong University

Qingdao, Shandong, China

West China Hospital，Sichuan University

Chengdu, Sichuan, China

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

The First People's Hospital of Yunnan Province

Kunming, Yunnan, China

The Third People's Hospital of Yunnan Province

Kunming, Yunnan, China

The Second People's Hospital of Qujing City

Qujing, Yunnan, China

Li Huili Hospital of Ningbo Medical Center, Zhejiang Province

Ningbo, Zhejing, China

Beijing Hospital

Beijing, , China

Beijing Tiantan Hospital, Capital Medical University

Beijing, , China

Jiading District Central Hospital of Shanghai Municipality

Shanghai, , China

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, , China

The Third Central Hospital of Tianjin

Tianjin, , China

Countries

China

Central Contacts

Chunyan Ma, Ph.D.

Role: CONTACT

cmu1h_mcy@126.com

86+13998816448

Guangyuan Li, PhD candidate

Role: CONTACT

604221697@@qq.com

86-15140191401

Facility Contacts

Jing Tian

Role: primary

Yanling Zheng

Role: primary

Xueling Liu

Role: primary

Yanling Che

Role: primary

Xiaoping Leng, PhD

Role: primary

Hong Ding

Role: primary

Haohui Zhu, PhD

Role: primary

Ao Li

Role: primary

Chunquan Zhang

Role: primary

Hui Wang

Role: primary

Xiaofeng Sun

Role: primary

Naihua Zhang

Role: primary

Dena Hong

Role: primary

Xiukun Hou, PhD

Role: primary

Linwei Hong

Role: primary

Li Yang

Role: primary

Li Li

Role: primary

Xiaorong Wen

Role: primary

Yu Wang

Role: primary

Fugang Mao

Role: primary

Rongping Ning

Role: primary

Renquan Wang

Role: primary

Caiping Zou

Role: primary

Junhong Ren, PhD

Role: primary

Wen He

Role: primary

Yingchun Wang

Role: primary

Lixin Jiang

Role: primary

Wenfeng Xiong

Role: primary

Yanmin Kan

Role: primary

Other Identifiers

MAP-UHF-01

Identifier Type: -

Identifier Source: org_study_id