Blood Pressure Follow-up Study in Two Chinese Cohorts(C-BPCS)

NCT ID: NCT02734472

Last Updated: 2017-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

5298 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Essential hypertension is a complex trait which results from interaction between environmental factors and genetic factors. The aim of this study is to investigate the effects of interaction between environmental factors and genetic factors on long-term blood pressure (BP) based on two established cohorts including "the cohort of Hanzhong adolescent hypertension study" and "the cohort of Mei county adult salt-sensitive hypertension study". Firstly, the Hanzhong cohort-based follow-up study is designed to observe the track of BP during the whole life time, and to explore the effects of many risk factors (such as salt-sensitivity, obesity et al) on long-term BP and the occurrence of hypertension, and also to analyze the relationship of different polymorphisms of sodium and potassium metabolism-related gene with BP changes and target organ damages. In addition, by using DNA samples collected from subjects of "Mei county adult salt-sensitive hypertension study"in which all participants had completed a chronic salt loading and potassium intervention trial, we attempt to examine the single nucleotide polymorphisms (SNPs) of sodium and potassium metabolism-related genes, as well as the relationship between these SNPs and BP responses to dietary sodium/potassium intervention, long-term BP change, the risk of hypertension and target organ damages were analyzed. This study would enable us to further explore the etiology of essential hypertension as well as to identify new genetic markers for predicting early hypertension and target organ damage.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is a longitudinal cohort follow-up study. The main contents include:(1)Questionnaire design: questionnaire is designed according to the research contents and purposes. The standard questionnaires will be used to collect the general information, dietary habits, lifestyle, medical history and family history etc.(2)Anthropometric measurements: blood pressure, height, body weight,waist and hip, pulse will be acquired by medical practitioners who received professional trainings based on World Health Organization (WHO) standards, and passed relevant examinations.(3) Blood and urine samples collection: morning fasting blood, nocturia, and 24-hour urine specimen will be collected by medical staffs, and blind tubes will be set up according to 5% of the total samples. Blood biochemistries including serum total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, fasting glucose, creatinine and hsCRP can be measured using automatic biochemical analyzer. The sodium and potassium concentrations in the urine will be measured by flame photometry. The total sodium and potassium excretions in urine in 24h were calculated by multiplying the concentration and 24-h volume of urine. (4) Auxiliary examinations: Auxiliary examinations including carotid intima-media thickness, endothelium-dependent vasodilation (FMD), measurements of brachial-ankle pulse wave velocity (baPWV) and electrocardiographic parameters. The measurement will be done in hospitals by medical practitioners who received professional trainings and passed relevant examinations. (5) Single nucleotide polymorphisms detection: based on our previous studies, sodium and potassium metabolism-related gene polymorphisms will be detected using MassARRAY technology. (6) Data processing and statistics: we should input the data to the database, and utilize softwares such as SPSS, STATA, Haploview and FBAT to analyze. (7) Quality control: ① Questionnaire is strictly designed and amended by epidemiologist and clinical experts. ② A standardized "Investigator Handbook" will be stipulated according to the guidelines. ③ Staff members are required to do a rigorous training and pass the exam. ④ The investigation process will be strictly supervised by the principal investigator. ⑤ Data entry use the parallel double entry method. ⑥ During laboratory testing, blank control and blind detection are applied to ensure the quality. ⑦ Data analysis is performed by 2-3 postgraduates, inconsistent data need to be double checked.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hanzhong cohort

A total of 4623 adolescents aged 6-15 years old in Hanzhong rural areas were recruited in 1987.During the follow-up period, the information about the incidence and risk factors of hypertension will be collected.

Incidence and risk factors of hypertension

Intervention Type OTHER

During the follow-up period,General information(age, sex, BMI, blood pressure, the history of drink and smoke, medical history, etc).Blood biochemistry parameters(Lipid, hsCRP levels, etc)and other laboratory examination parameters(arterial stiffness,IMT, FMD) will be collected.

Mei county cohort

A total of 675 individuals from 126 families were recruited in this family-based dietary intervention study. A community-based BP screening was conducted among adults aged 18-60 years in the study villages. The probands who had a mean systolic BP (SBP) between 130-160 mmHg and/or a diastolic BP (DBP) between 85-100 mmHg and no use of antihypertensive medications and their parents, siblings, spouses, and offspring were recruited in this study. During the follow-up period, the information about the incidence and risk factors of hypertension will be collected.

Incidence and risk factors of hypertension

Intervention Type OTHER

During the follow-up period,General information(age, sex, BMI, blood pressure, the history of drink and smoke, medical history, etc).Blood biochemistry parameters(Lipid, hsCRP levels, etc)and other laboratory examination parameters(arterial stiffness,IMT, FMD) will be collected.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Incidence and risk factors of hypertension

During the follow-up period,General information(age, sex, BMI, blood pressure, the history of drink and smoke, medical history, etc).Blood biochemistry parameters(Lipid, hsCRP levels, etc)and other laboratory examination parameters(arterial stiffness,IMT, FMD) will be collected.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Hanzhong cohort of Adolescent Hypertension Study:

* adolescents aged 6-15 years old in over 20 schools of three towns (Qili, Laojun and Shayan) in Hanzhong, Shaanxi, China.
2. Mei county cohort of adult salt-sensitive hypertension study:

* Han individuals in rural northern China
* adults aged 18-60 years
* individuals who had a mean systolic BP (SBP) between 130-160 mmHg and/or a diastolic BP (DBP) between 85-100 mmHg and no use of antihypertensive medications were identified as the proband
* the probands'parents,siblings, spouses, and offspring were recruited for the study.

Exclusion Criteria

* Secondary hypertension
* a history of severe cardiovascular disease
* chronic kidney disease or liver disease
* unable to complete the examination
* unable/refuse to sign the informed consent form
Minimum Eligible Age

6 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jianjun Mu, doctor

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jianjun Mu, doctor

Role: CONTACT

0086-029-85323804

Chao Chu, master

Role: CONTACT

0086-029-85323800

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jianjun Mu, doctor

Role: primary

0086-029-85323804

Chao chu, master

Role: backup

0086-029-85323800

References

Explore related publications, articles, or registry entries linked to this study.

Mu J, Zheng S, Lian Q, Liu F, Liu Z. Evolution of blood pressure from adolescents to youth in salt sensitivies: a 18-year follow-up study in Hanzhong children cohort. Nutr J. 2012 Sep 14;11:70. doi: 10.1186/1475-2891-11-70.

Reference Type RESULT
PMID: 22978814 (View on PubMed)

Liu F, Zheng S, Mu J, Chu C, Wang L, Wang Y, Xiao H, Wang D, Cao Y, Ren K, Liu E, Yuan Z. Common variation in with no-lysine kinase 1 (WNK1) and blood pressure responses to dietary sodium or potassium interventions- family-based association study. Circ J. 2013;77(1):169-74. doi: 10.1253/circj.cj-12-0900. Epub 2012 Oct 12.

Reference Type RESULT
PMID: 23059770 (View on PubMed)

Wang L, Chang MK, Yue XM, Guo YJ, Yao YN, Liu NR, Yang BB, Niu ZJ, Gao WH, Li H, Wang Y. Associations of Genetic Variations in the NR3C2 With Salt Sensitivity, Longitudinal Blood Pressure Changes, and Incidence of Hypertension in Chinese Adults. J Clin Hypertens (Greenwich). 2025 Sep;27(9):e70137. doi: 10.1111/jch.70137.

Reference Type DERIVED
PMID: 40932182 (View on PubMed)

Zhang X, Yao S, Wang Y, Chu C, Du M, Mu J. Associations of microRNA Gene Polymorphisms With Salt Sensitivity, Longitudinal Blood Pressure Changes, and Hypertension Incidence in the Chinese Population. J Clin Hypertens (Greenwich). 2025 Feb;27(2):e70019. doi: 10.1111/jch.70019.

Reference Type DERIVED
PMID: 39994918 (View on PubMed)

Liao YY, Wang D, Chu C, Man ZY, Wang Y, Ma Q, Chen C, Sun Y, Mu JJ. Long-term burden and increasing trends of body mass index are linked with adult hypertension through triglyceride-glucose index: A 30-year prospective cohort study. Nutr Metab Cardiovasc Dis. 2024 Sep;34(9):2134-2142. doi: 10.1016/j.numecd.2024.05.014. Epub 2024 May 18.

Reference Type DERIVED
PMID: 39003135 (View on PubMed)

Guo T, Zheng S, Chen T, Chu C, Ren J, Sun Y, Wang Y, He M, Yan Y, Jia H, Liao Y, Cao Y, Du M, Wang D, Yuan Z, Wang D, Mu J. The association of long-term trajectories of BMI, its variability, and metabolic syndrome: a 30-year prospective cohort study. EClinicalMedicine. 2024 Feb 12;69:102486. doi: 10.1016/j.eclinm.2024.102486. eCollection 2024 Mar.

Reference Type DERIVED
PMID: 38370536 (View on PubMed)

Niu ZJ, Yao S, Zhang X, Mu JJ, Du MF, Zou T, Chu C, Liao YY, Hu GL, Chen C, Wang D, Ma Q, Yan Y, Jia H, Wang KK, Sun Y, Yan RC, Man ZY, Ren DF, Wang L, Gao WH, Li H, Wu YX, Li CH, Gao K, Zhang J, Yang TL, Wang Y. Associations of genetic variations in NEDD4L with salt sensitivity, blood pressure changes and hypertension incidence in Chinese adults. J Clin Hypertens (Greenwich). 2022 Oct;24(10):1381-1389. doi: 10.1111/jch.14566. Epub 2022 Aug 30.

Reference Type DERIVED
PMID: 36039789 (View on PubMed)

Yuan Y, Mu JJ, Chu C, Zheng WL, Wang Y, Hu JW, Ma Q, Yan Y, Liao YY, Chen C. Effect of metabolically healthy obesity on the development of arterial stiffness: a prospective cohort study. Nutr Metab (Lond). 2020 Jul 2;17:50. doi: 10.1186/s12986-020-00474-8. eCollection 2020.

Reference Type DERIVED
PMID: 32625239 (View on PubMed)

Yuan Y, Chu C, Zheng WL, Ma Q, Hu JW, Wang Y, Yan Y, Liao YY, Mu JJ. Body Mass Index Trajectories in Early Life Is Predictive of Cardiometabolic Risk. J Pediatr. 2020 Apr;219:31-37.e6. doi: 10.1016/j.jpeds.2019.12.060. Epub 2020 Feb 12.

Reference Type DERIVED
PMID: 32061408 (View on PubMed)

Yuan Y, Hu JW, Wang Y, Wang KK, Zheng WL, Chu C, Ma Q, Yan Y, Liao YY, Mu JJ. Association between atherogenic index of plasma and subclinical renal damage over a 12-year follow-up: Hanzhong adolescent hypertension study. Eur J Clin Nutr. 2020 Feb;74(2):278-284. doi: 10.1038/s41430-019-0530-x. Epub 2019 Nov 14.

Reference Type DERIVED
PMID: 31728032 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

XJTU1AF-CRF-2015-006

Identifier Type: -

Identifier Source: org_study_id