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Salt-sensitive Hypertension Study in Lantian County (SHSL)

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ClinicalTrials.gov Identifier: NCT02915315
Recruitment Status : Unknown
Verified September 2016 by First Affiliated Hospital Xi'an Jiaotong University.
Recruitment status was:  Not yet recruiting
First Posted : September 27, 2016
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

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.

Condition or disease Intervention/treatment
Hypertension Dietary Supplement: salt

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Genetics Study of Salt-Sensitive Hypertension in a Chinese Population
Estimated Study Start Date : February 28, 2017
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Sodium

Group/Cohort Intervention/treatment
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).
Dietary Supplement: salt
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.
Other Name: Sodium Chloride

High -salt diet
After washout period, all subjects will be instructed to maintain a 18g of salt or 307.8mmol of sodium per day.
Dietary Supplement: salt
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.
Other Name: Sodium Chloride




Primary Outcome Measures :
  1. blood pressure value(mmHg) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Ambulatory Blood Pressure Monitoring(mmHg) [ Time Frame: 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

  2. Microalbuminuria(mg/24h) [ Time Frame: 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.

  3. Increased arterial stiffness(baPWV,mm/s) [ Time Frame: 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.

  4. DNA methylation [ Time Frame: 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.

  5. LncRNA [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
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.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02915315


Contacts
Contact: Jianjun Mu, doctor 0086-029-85323804 mujjun@163.com
Contact: Wenling Zheng, doctor 0086-029-85323804 zwl08201032@126.com

Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
Principal Investigator: Jianjun Mu, doctor First Affiliated Hospital Xi'an Jiaotong University

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT02915315     History of Changes
Other Study ID Numbers: NSFC(81570381)
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
blood pressure
Hypertrophy
Left Ventricular
arterial Stiffness
Proteinuria
baPWV
ambulatory Blood Pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases