Salt-sensitive Hypertension Study in Lantian County (SHSL)
23 de fevereiro de 2017 atualizado por: First Affiliated Hospital Xi'an Jiaotong University
Genetics Study of Salt-Sensitive Hypertension in a Chinese Population
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.
Visão geral do estudo
Descrição detalhada
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)
Dietary intervention: The dietary intervention comprise a 3-day baseline observation period, a low-salt diet for 7 days (3g of salt or 51.3mmol of sodium per day) and a high-salt diet for 7 days (18g of salt or 307.8mmol of sodium 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 21-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 prepackaged salt to the meals of individual subjects as indicated by the study protocol.
(4) Blood and urine samples collection: morning fasting blood, nocturnal enuresis, 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.
(5) DNA methylation and LncRNA detection: Using a method of modifying a hydrogen sulfite salt and gene chip technology to detect DNA methylation and LncRNA.
(6) LncRNA: LncRNA will be measured with gene chip technology after the high salt intervention period.
(7) 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.
(8) Data processing and statistics: the investigators should input the data to the database, and utilize software such as SPSS, STATA, Haploview and FBAT to analyze.
(9)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.
⑦Data analysis is performed by 2-3 postgraduates, inconsistent data need to be double checked.
Tipo de estudo
Observacional
Inscrição (Antecipado)
70
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra de Probabilidade
População do estudo
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.
Descrição
Inclusion Criteria:
- 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.
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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Baseline survey period
All subjects will continue a normal diet for 3 days in which questionnaire design and anthropometric measurements will be implemented.
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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).
|
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.
Outros nomes:
|
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High -salt diet
After washout period, all subjects will be instructed to maintain a 18g of salt or 307.8mmol of sodium per day.
|
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.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
blood pressure value(mmHg)
Prazo: The first day of the three-day baseline survey period.
|
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.
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The first day of the three-day baseline survey period.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Ambulatory Blood Pressure Monitoring（mmHg）
Prazo: Second day of the three-day baseline survey period
|
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.
Ambulatory blood pressure（mmHg）will be measured with Omron Ambulatory Blood Pressure Monitor during the three-day baseline survey period
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Second day of the three-day baseline survey period
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Microalbuminuria（mg/24h）
Prazo: Second day of the three-day baseline survey period
|
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.
On the second day, 24-hour urinary will be collected and the concentrations of microalbuminuria in the urine sample will be measured with Hitachi biochemical analyzer.
The 24-h microalbuminuria（mg/24h）of each subject is calculated as the concentration of microalbuminuria multiplied by the 24-h urine volume of each individual.
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Second day of the three-day baseline survey period
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Increased arterial stiffness（baPWV,mm/s）
Prazo: Second day of the three-day baseline survey period
|
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.
Brachial-ankle pulse wave velocity（baPWV, mm/s）will be measured with Noninvasive automatic waveform analyzer during the three-day baseline survey period.
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Second day of the three-day baseline survey period
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DNA methylation
Prazo: Last day of the low salt or high salt intervention period
|
The study will last approximately 3 months (Oct 2016 to Dec 2016).
During this period, each subject will receive a seven-day high salt intervention subsequent to a seven-day low salt intervention.
DNA methylation will be measured with a method of modifying a hydrogen sulfite salt at the last day of the low salt or high salt intervention.
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Last day of the low salt or high salt intervention period
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LncRNA
Prazo: Last day of the low salt or high salt intervention period
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The study will last approximately 3 months (Oct 2016 to Dec 2016).
During this period, each subject will receive a seven-day high salt intervention subsequent to a seven-day low salt intervention.
IncRNA will be measured with gene chip technology at the last day of the low salt or high salt intervention.
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Last day of the low salt or high salt intervention period
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Jianjun Mu, doctor, First Affiliated Hospital Xi'an Jiaotong University
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
- 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.
- Wang 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.
- Wang 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.
- Zhang 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Antecipado)
28 de fevereiro de 2017
Conclusão Primária (Antecipado)
1 de março de 2017
Conclusão do estudo (Antecipado)
1 de março de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
21 de setembro de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de setembro de 2016
Primeira postagem (Estimativa)
27 de setembro de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de fevereiro de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de fevereiro de 2017
Última verificação
1 de setembro de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NSFC(81570381)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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