Salt-sensitive Hypertension Study in Lantian County
SHSL
Genetics Study of Salt-Sensitive Hypertension in a Chinese Population
1 other identifier
observational
70
0 countries
N/A
Brief Summary
Essential hypertension is a complex trait which results from interaction between environmental factors and genetic factors. Our study aimed to detect the differential expression of LncRNAs and epigenetic changes such as DNA methylation associated with salt sensitive hypertension in human based on a chronic salt loading study conducted in Lantian county, China. Firstly, a chronic salt loading study will be conducted in a Chinese population to differentiate salt-sensitive and salt-resistant individuals. Second, LncRNAs and DNA methylation Chip analysis will be performed using samples collected from salt-sensitive and salt resistant individual, and the results will be analyzed by modern bioinformatics methods to seek for differential genetic markers. In addition, the investigators also try to examine the effects of chronic salt loading on BP, ambulatory BP, microalbuminuria and baPWV and other biochemical indexes. This project had great significance to reveal molecular genetics mechanism in the development of salt, salt-sensitive and hypertension.
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for all trials
Started Feb 2017
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2016
CompletedFirst Posted
Study publicly available on registry
September 27, 2016
CompletedStudy Start
First participant enrolled
February 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedFebruary 27, 2017
September 1, 2016
1 day
September 21, 2016
February 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
blood pressure value(mmHg)
The study will last approximately 3 months (Oct 2016 to Dec 2016). During this period, each subject will receive a three-day baseline survey examination. Three BPs (mmHg) measurement will be obtained using a Blood Pressure Monitor on the first day of the three-day baseline survey period.
The first day of the three-day baseline survey period.
Secondary Outcomes (5)
Ambulatory Blood Pressure Monitoring（mmHg）
Second day of the three-day baseline survey period
Microalbuminuria（mg/24h）
Second day of the three-day baseline survey period
Increased arterial stiffness（baPWV,mm/s）
Second day of the three-day baseline survey period
DNA methylation
Last day of the low salt or high salt intervention period
LncRNA
Last day of the low salt or high salt intervention period
Study Arms (3)
Baseline survey period
All subjects will continue a normal diet for 3 days in which questionnaire design and anthropometric measurements will be implemented.
Low-salt diet
All subjects will be instructed to maintain a low-salt diet for 7 days (3g of salt or 51.3mmol of sodium per day).
High -salt diet
After washout period, all subjects will be instructed to maintain a 18g of salt or 307.8mmol of sodium per day.
Interventions
The protocol comprise a questionnaire survey and physical examination during a 3-day baseline observation period, a low-salt diet for 7 days (3g of salt per day) and a high-salt diet for 7 days (18g of salt per day). During the baseline period, each subject is given detailed dietary instructions to avoid table salt, cooking salt, and high-salt foods for the 17-day study duration. To ensure compliance of study participants with the intervention program, they are required to have their breakfast, lunch, and dinner at the study kitchen under supervision of the study staff during the entire study period. All foods are cooked without salt. Onsite study staff members add repackaged salt to the meals of individual subjects as indicated by the study protocol.
Eligibility Criteria
The study population is ready to recruit from Shaanxi Lantian County, aged 18-65 years old and sex is not limited. The exclusion criteria were hypertension, use of antihypertensive medication, clinical cardiovascular disease, chronic liver disease, chronic kidney disease, or diabetes mellitus, pregnancy, or high alcohol consumption.
You may qualify if:
- Han individuals in rural northern China
- adults aged 18-65 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (5)
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.
PMID: 22978814RESULTLiu 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.
PMID: 23059770RESULTWang Y, Liu FQ, Wang D, Mu JJ, Ren KY, Guo TS, Chu C, Wang L, Geng LK, Yuan ZY. Effect of salt intake and potassium supplementation on serum renalase levels in Chinese adults: a randomized trial. Medicine (Baltimore). 2014 Jul;93(6):e44. doi: 10.1097/MD.0000000000000044.
PMID: 25058146RESULTWang Y, Jia H, Gao WH, Zou T, Yao S, Du MF, Zhang XY, Chu C, Liao YY, Chen C, Wang D, Ma Q, Hu JW, Wang KK, Yan Y, Sun Y, Hu GL, Niu ZJ, Zhou HW, Zhang X, Wang X, Li CH, Chen FY, Gao K, Zhang J, Guan YJ, Chang J, Yang TL, Mu JJ. Associations of plasma PAPP-A2 and genetic variations with salt sensitivity, blood pressure changes and hypertension incidence in Chinese adults. J Hypertens. 2021 Sep 1;39(9):1817-1825. doi: 10.1097/HJH.0000000000002846.
PMID: 33783375DERIVEDZhang J, Yin Y, Chen L, Chu C, Wang Y, Lv Y, He M, Martin M, Huang PH, Mu JJ, Shyy JY, Yuan ZY. Short-Term High-Salt Diet Increases Corin Level to Regulate the Salt-Water Balance in Humans and Rodents. Am J Hypertens. 2018 Jan 12;31(2):253-260. doi: 10.1093/ajh/hpx148.
PMID: 28985241DERIVED
Biospecimen
Lantian county adult salt-sensitive hypertension study is a family-based dietary interventional study. Whole blood specimen was collected from each participant who underwent a chronic salt load and potassium supplementation trial.Genomic DNA was extracted from whole blood specimen using the GOLDMAG Whole Blood Genomic DNA Purification Kit.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianjun Mu, doctor
First Affiliated Hospital Xi'an Jiaotong University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2016
First Posted
September 27, 2016
Study Start
February 28, 2017
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
February 27, 2017
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share