PrediabetesMAP-UHFNCT07271745
Multicenter Study on Early Arterial Changes in Prediabetic Patients Evaluated by Ultra-High-Frequency Ultrasound
An observational study of Prediabetes, run by Chunyan Ma at 30 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes
- How many people
- 1,740 participants
- Where
- 30 sitesChina
- Study dates
- 15 Dec 2025to 31 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 300 prediabetic patients were selected from the physical examination center and outpatient department, and 1,440 healthy subjects were enrolled.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
China30 sites
Anshan Central Hospital
Anshan, Liaoning
Naihua Zhang
Beijing Hospital
Beijing, 100000
Junhong Ren, PhD
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100000
Wen He
China-Japan Union Hospital of Jilin University
Changchun, Jinlin
Hui Wang
The First Hospital of Jilin University
Changchun, Jinlin
Xiaofeng Sun
Chaoyang Central Hospital
Chaoyang, Liaoning
Dena Hong
West China Hospital，Sichuan University
Chengdu, Sichuan
Xiaorong Wen
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
Xiukun Hou, PhD
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Jing Tian
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Yanling Zheng
The First Affiliated Hospital of Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang
Yanling Che
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Xiaoping Leng, PhD
The Second Hospital of Heilongjiang Province
Harbin, Heilongjiang
Hong Ding
Jiamusi Central Hospital, Heilongjiang Province
Jiamusi, Heilongjiang
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Yu Wang
The First People's Hospital of Yunnan Province
Kunming, Yunnan
Fugang Mao
The Third People's Hospital of Yunnan Province
Kunming, Yunnan
Rongping Ning
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Chunquan Zhang
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu
Ao Li
The First Affiliated Hospital of Guangxi University of Chinese Medicine
Nanning, Guangxi
Xueling Liu
Li Huili Hospital of Ningbo Medical Center, Zhejiang Province
Ningbo, Zhejing
Caiping Zou
Qilu Hospital (Qingdao Branch) of Shandong University
Qingdao, Shandong
Li Li
The Second People's Hospital of Qujing City
Qujing, Yunnan
Renquan Wang
Jiading District Central Hospital of Shanghai Municipality
Shanghai
Yingchun Wang
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Lixin Jiang
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai
Wenfeng Xiong
The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning
Linwei Hong
The Third Central Hospital of Tianjin
Tianjin
Yanmin Kan
Tongliao People's Hospital of Inner Mongolia Autonomous Region
Tongliao, Neimenggu
Li Yang
Henan Provincial People's Hospital
Zhengzhou, Henan
Haohui Zhu, PhD
About this study
Official title: Multicenter Study on Early Arterial Changes in Prediabetic Patients Evaluated by Ultra-High-Frequency Ultrasound（MAP-UHF Study）
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.
Read the 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
- Keywords
- Ultra-High-Frequency Ultrasound, Prediabetic, Arterial Changes
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the thickness of the arterial intima (mm), media (mm), and intima-media (mm) respectively
Measuring the thickness of the arterial intima and media separately can more early and accurately reflect the degree of vascular lesions in different diseases.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,740 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Chunyan Ma
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Provincial People's Hospital, Beijing Tiantan Hospital
- Responsible party
- Sponsor-investigator, Chunyan Ma, First Hospital of China Medical University
- Investigators
- Chunyan Ma, Ph.D., Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271745
- Sponsor's protocol ID
- MAP-UHF-01
- Acronym
- MAP-UHF
- Status last verified
- Dec 2025
- First submitted
- 20 Aug 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study on Early Arterial Changes in Prediabetic Patients Evaluated by Ultra-High-Frequency Ultrasound（MAP-UHF Study）
- ClinicalTrials.gov ID
- NCT07271745
- Acronym / sponsor ID
- MAP-UHF / MAP-UHF-01
- Conditions
- Prediabetes
- Keywords
- Ultra-High-Frequency Ultrasound, Prediabetic, Arterial Changes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,740 participants (estimated)
- Lead sponsor
- Chunyan MaUniversity, hospital or other
- Collaborators
- Henan Provincial People's Hospital, Beijing Tiantan Hospital
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 300 prediabetic patients were selected from the physical examination center and outpatient department, and 1,440 healthy subjects were enrolled.
Key inclusion criteria (8 listed)
- 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);
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure the thickness of the arterial intima (mm), media (mm), and intima-media (mm) respectively
Time frame: 1 day
Measuring the thickness of the arterial intima and media separately can more early and accurately reflect the degree of vascular lesions in different diseases.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chunyan Ma, Ph.D. principal investigator
First Hospital of China Medical University
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prediabetes, run by Chunyan Ma at 30 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunyan Ma, Ph.D. (86+13998816448, cmu1h_mcy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the thickness of the arterial intima (mm), media (mm), and intima-media (mm) respectively (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.