Clinical trial NCT05455099: A Multicenter Study of Ultrafast Pulse Wave Velocity in Obese Chinese Han Adults
Official title: Multicenter Study of Carotid Artery Ultrafast Pulse Wave Velocity (UFPWV) in Obese Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carotid Artery Diseases
Keywords: Obesity
Pulse Wave Velocity
Carotid Artery Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population description \* (only for observational study): 2400 overweight or obese adults will be recruited from physical examination center. They will be assigned to overweight group (body mass index 24.0-27.9 kg/m²; n = 1200) and obese group (body mass index ≥ 28.0 kg/m²; n = 1200).

Brief summary: Ultrafast pulse wave velocity (UFPWV) is a novel non-invasive method developed recently to evaluate pulse wave velocity (PWV). This multi-center clinical trial aims to evaluate the feasibility of UFPWV in the evaluation of the carotid stiffness of overweight and obese population and investigate the correlation between overweight/obesity and subclinical atherosclerosis, providing an important theoretical basis for early monitoring and risk assessment of carotid atherosclerosis in overweight/obese people.

Detailed description: In recent years, with the change of people's lifestyle and dietary structure, overweight and obesity have become serious problems threatening public health. During 1975-2016, the worldwide prevalence of overweight and obesity increased year by year. By 2016, about 40% of adults were overweight and obese, of which 2.3% of men and 5.0% of women were severely obese (i.e. body mass index ≥ 35 kg/m²). The number of overweight and obese people in China is growing rapidly. Report on the Nutrition and Chronic Disease Status of Chinese Residents (2020 version) shows that over 50% Chinese obese adults have overweight and obesity. Overweight and obesity have become one of the most serious public health problems in China. Previous studies have found that overweight and obesity are often accompanied by abnormalities of blood glucose, blood pressure and blood lipids, leading to dysfunction of vascular endothelial cells and changes in the structure and function of vascular wall, which are closely related to atherosclerosis. Therefore, early detection of atherosclerosis and timely intervention measures can effectively prevent and reduce the occurrence and development of atherosclerosis.

At present, carotid intima-media thickness (CIMT) can be clinically used to evaluate carotid atherosclerosis, which can evaluate the morphological changes of carotid artery, but it cannot be used to evaluate the stiffness of carotid artery. PWV is the gold standard for evaluating arterial stiffness. However, the conventional PWV measurement method can evaluate the stiffness of long-distance artery. Evaluated outcomes are affected by height and body mass, and therefore, the evaluation accuracy of PWV can be limited.

UFPWV is a novel noninvasive method developed in recent years to evaluate PWV. It can be used to evaluate PWV of local artery. Different from the conventional PWV method, UFPWV has a very high frame rate, up to 2000 frames/s, and can track the movement of arterial wall at specific segments in real time. UFPWV can obtain PWV at the beginning and end of systole by tracking and automatic analysis. In recent years, increasing attention has been paid to the role of UFPWV in the evaluation of carotid artery. UFPWV has been used in the study of carotid arteries in normal people, vascular Ehlers-Danlos syndrome, hypertension, hyperlipidemia, diabetes and other groups.

In the early stage, First Hospital of China Medical University participated in the national multi- center, large-sample trial: multi-center study on normal value of ultrafast pulse wave velocity in Chinese Han adults. The center has accumulated rich experience during the project implementation. The center determined the normal reference value of UFPWV for Chinese Han adults and verified that UFPWV has good measurement repeatability. At the same time, the project team had applied UFPWV technology to study early carotid atherosclerosis in patients with metabolic syndrome and coronary slow flow phenomenon. The results show that UFPWV has been accelerated without marked thickening of CIMT, which preliminarily proves that UFPWV can accurately and sensitively detect early carotid atherosclerosis.

This study aims to evaluate the feasibility of UFPWV in carotid stiffness of overweight and obese people, and correlate overweight/obesity with subclinical atherosclerosis, so as to provide an important theoretical basis for early monitoring and risk assessment of carotid atherosclerosis in overweight/obese people.

Eligibility criteria: Inclusion Criteria:

* Han nationality;
* Age ≥18 - 80 years;
* Body mass index ≥ 24 kg/m²;
* Blood pressure ≥ 90/60 mmHg (1 mmHg = 0.133 kPa);
* Fasting blood glucose level ≥ 3.9 mmol/L;
* No abnormality in cardiovascular and respiratory system found by physical examination;
* Normal findings in routine blood test, routine urine test, liver function and kidney function;
* No history of cardiovascular disease, respiratory system disease, liver and kidney disease except hypertension, diabetes or hyperlipidemia;
* Electrocardiogram examination showed no arrhythmia or myocardial infarction;
* No structural cardiac abnormalities (such as moderate or above cardiac valve regurgitation, abnormal ventricular wall motion, congenital heart disease, cardiomyopathy, pericardial lesions) were found by echocardiography, and left ventricular ejection fraction ≥ 53%;
* No marked abnormality in ultrasonography of the liver, gallbladder, pancreas, spleen and kidney;
* Normal findings in carotid ultrasound examination.

Exclusion Criteria:

* Hepatorenal insufficiency;
* Respiratory diseases: Acute or chronic respiratory diseases;
* Large artery diseases: aortic dilatation, aortic dissection, aortic coarctation, multiple Takayasu arteritis, etc;
* Special diseases: history of malignant tumor, acute or chronic infection, moderate to severe anemia, disability or mental disorder, autoimmune diseases, acquired immunodeficiency syndrome, etc;
* Pregnant or lactating women;
* Recent history of surgery and trauma;
* Organ transplant;
* Poor ultrasonic image quality, which cannot meet analysis requirement.

Primary outcomes:
measure: Pulse wave velocity（m/s）at the ending of the systole (ES) of carotid artery
timeFrame: 1 day after admission
Secondary outcomes:
measure: Pulse wave velocity（m/s）at the beginning of the systole (BS) of carotid artery
timeFrame: 1 day after admission
measure: Carotid artery intima-media thickness (IMT)
timeFrame: 1 day after admission
measure: Serum biochemical index
timeFrame: 1 day after admission
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Three Gorges Central Hospital
state: Chongqing
city: Guangzhou
country: China
facility: Guangdong Province Hospital of Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Panyu Central Hospital
state: Guangdong
city: Guangzhou
country: China
facility: the Fifth Affiliated Hospital of Southern Medical University
state: Guangdong
city: Shijiazhuang
country: China
facility: Hebei General Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: the First Hospital of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Xiangyang
country: China
facility: Xiangyang No.1 Peoples Hospital
state: Hubei
city: Nanjing
country: China
facility: Affiliated Hospital of Nanjing University of Chinese Medicine
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Official Hospital
state: Jiangsu
city: Dalian
country: China
facility: Dalian Municipal Central Hospital
state: Liaoning
city: Jinzhou
country: China
facility: the First Affiliated Hospital of Jinzhou Medical University
state: Liaoning
city: Shenyang
country: China
facility: Affiliated Central Hospital of Shenyang Medical College
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Xi'an
country: China
facility: Xi'an Daxing Hospital
state: Shaanxi
city: Binzhou
country: China
facility: Binzhou Medical University Hospital
state: Shandong
city: Guang'an
country: China
facility: Yuechi People's Hospital
state: Sichuan
city: Leshan
country: China
facility: People's Hospital of Leshan
state: Sichuan
city: Mianyang
country: China
facility: Jiangyou People's Hospital
state: Sichuan
city: Tianjin
country: China
facility: NHC Key Laboratory of Hormones and Development, CHU Hsien-i Memorial Hospital and Tianjin Institute of Endocrinology
state: Tianjin
city: Gejiu
country: China
facility: Gejiu People's Hospital
state: Yunnan
Study officials:
affiliation: the First Hospital of China Medical Univeristy
name: Chunyan Ma, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: