- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02915315
Salt-sensitive Hypertension Study in Lantian County (SHSL)
23. februar 2017 oppdatert av: 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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Forventet)
70
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
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).
|
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.
Andre navn:
|
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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
blood pressure value(mmHg)
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Ambulatory Blood Pressure Monitoring(mmHg)
Tidsramme: 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
|
Second day of the three-day baseline survey period
|
Microalbuminuria(mg/24h)
Tidsramme: 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.
|
Second day of the three-day baseline survey period
|
Increased arterial stiffness(baPWV,mm/s)
Tidsramme: 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.
|
Second day of the three-day baseline survey period
|
DNA methylation
Tidsramme: 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.
|
Last day of the low salt or high salt intervention period
|
LncRNA
Tidsramme: 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.
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Jianjun Mu, doctor, First Affiliated Hospital Xi'an Jiaotong University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
28. februar 2017
Primær fullføring (Forventet)
1. mars 2017
Studiet fullført (Forventet)
1. mars 2017
Datoer for studieregistrering
Først innsendt
21. september 2016
Først innsendt som oppfylte QC-kriteriene
22. september 2016
Først lagt ut (Anslag)
27. september 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. februar 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. februar 2017
Sist bekreftet
1. september 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NSFC(81570381)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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