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Salt-sensitive Hypertension Study in Lantian County (SHSL)

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.

연구 개요

상태

알려지지 않은

정황

상세 설명

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.

연구 유형

관찰

등록 (예상)

70

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

샘플링 방법

확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.
다른 이름들:
  • 염화나트륨
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.
다른 이름들:
  • 염화나트륨

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
blood pressure value(mmHg)
기간: 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.
The first day of the three-day baseline survey period.

2차 결과 측정

결과 측정
측정값 설명
기간
Ambulatory Blood Pressure Monitoring(mmHg)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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.
Last day of the low salt or high salt intervention period

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Jianjun Mu, doctor, First Affiliated Hospital Xi'an Jiaotong University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (예상)

2017년 2월 28일

기본 완료 (예상)

2017년 3월 1일

연구 완료 (예상)

2017년 3월 1일

연구 등록 날짜

최초 제출

2016년 9월 21일

QC 기준을 충족하는 최초 제출

2016년 9월 22일

처음 게시됨 (추정)

2016년 9월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 2월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 2월 23일

마지막으로 확인됨

2016년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NSFC(81570381)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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