跳至主要内容
临床试验/NCT03569735
NCT03569735招募中不适用

Nanshan Elderly Cohort Study:a Community-based Prospective Cohort Study in Nanshan, Shenzhen Residents

Sun Yat-sen University2 个研究点 分布在 1 个国家目标入组 20,000 人开始时间: 2018年5月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20,000
试验地点
2
主要终点
Cardiovascular diseases (occurrence of cardiovascular diseases)

研究概览

简要总结

Objective: The Nanshan Elderly Cohort Study (NECS) aims to investigate the nutritional, as well as other environmental and genetic factors of chronic diseases, such as cardio-metabolic diseases.

Study design: NECS is a community-based prospective cohort study. Participants: About 10000-20000 apparently healthy residents, living in Nanshan, Shenzhen (South China) for >5 years, aged ≥ 65 years, will be recruited between 2018 and 2019.

Visits and Data Collection: Participants will be followed up approximately every 3 years by invited to the Community Healthcare Service Centre. At each survey, face-to-face interviews, anthropometric measurements, ultrasonography examination, electrocardiogram test and specimen collection will be conducted.

Key variables:

  1. Face-to-face interviews: Structured questionnaires will be used to collect the participants' socio-demographic characteristics, lifestyles, habitual dietary intake, physical activity, history of chronic diseases, use of supplements and medications, family history, psychological health and cognitive function.

  2. Physical examinations: Anthropometric measurements, blood pressure tests, handgrip strength, and usual gait speed.

  3. Ultrasonography examinations: Ultrasonography examination will be performed to determine carotid artery intima-media thickness and plaque, fatty liver.

  4. Electrocardiogram test: Electrocardiogram test is to obtain information about the structure and function of the heart.

  5. Specimen collections: Overnight fasting blood sample, early morning first-void urine sample and faeces samples will be collected and stored at -80°C till tests.

  6. Laboratory tests:

  7. Blood tests: Metabolic syndrome-related indices; nutritional indices; inflammatory markers; sexual hormones; genetic markers.

  8. Urinary tests: Flavonoids and flavones, minerals, creatinine and renal function related markers.

  9. Fecal test: Gut microbiota and related metabolites.

  10. Morbidity and mortality: Relevant data will be also retrieved via local multiple Health information systems.

  11. Others: Many other laboratory tests or instrument tests will be developed depended on needs and resources in future.

详细描述

Objective: The Nanshan Elderly Cohort Study (NECS) aims to investigate the nutritional, as well as other environmental and genetic factors of chronic diseases, such as hypertension, type 2 diabetes mellitus, cardiovascular diseases, stroke, obesity, metabolic syndrome, chronic kidney disease, cancer and sarcopenia.

Study design: NECS is a community-based prospective cohort study. Participants: Healthy residents who had lived in Nanshan, Shenzhen (South China) for >5 years, aged ≥ 65 years are eligible. Participants would be excluded if they are confirmed to have serious chronic diseases, such as cardiovascular disease, liver or renal failure, or cancer. About 10000-20000 apparently healthy residents will be recruited between 2018 and 2019.

Visits and Data Collection: Participants will be followed up approximately every 3 years by invited to the Community Healthcare Service Centre. At each survey, face-to-face interviews, anthropometric measurements, ultrasonography examinations, electrocardiogram test and specimen collection will be conducted.

Key variables:

  1. Face-to-face interviews: Structured questionnaires will be used to collect the participants' socio-demographic characteristics (e.g., age, sex and household income, education level), lifestyles (smoking, passive smoking, alcohol and tea drinking), habitual dietary intake (a 62-item quantitative food frequency questionnaire), physical activity, history of chronic diseases, use of supplements and medications, family history, psychological health (Self-Rating Anxiety Scale, SAS), social support and participation, cognitive function (Mini-Mental State Examinations, MMSE);
  2. Physical examinations: Anthropometric measurements (weight, height, waist, hip and neck circumference, etc.), blood pressure tests, handgrip strength, and usual gait speed.
  3. Ultrasonography examinations: Ultrasonography examination of the carotid artery and upper abdominal organs (e.g., liver and kidney) will be performed to determine carotid artery intima-media thickness and plaque, fatty liver.
  4. Electrocardiogram test: Electrocardiogram test is to obtain information about the structure and function of the heart.
  5. Specimen collections: Overnight fasting blood sample will be collected and separated into serum, plasma, red blood cell and leukocyte within two hours. Early morning first-void urine sample and faeces samples will be collected. All specimens will separated and stored at -80°C till tests.
  6. Laboratory tests:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: ≥ 65 years;
  • Living in Nanshan, Shenzhen for at least 5 years;

排除标准

  • Had a history of hospital-confirmed diabetes, failure(s) of heart, liver, or kidney, cancer, CVD events;
  • On special diet due to a disease or weight control;
  • Mental and physical disability;
  • Likely to move to other city within 5 years;
  • Did not want to attend any one item of the survey or sample collection.

结局指标

主要结局

Cardiovascular diseases (occurrence of cardiovascular diseases)

时间窗: Up to 10 years

The investigators will track for occurrence of cardiovascular diseases by follow-up surveys and annual record linkage to the population-based disease or death registry collected by the Shenzhen Center for Disease Control and Prevention, and Health Insurance Bureau. All cases will be verified by medical record reviews.

Cognitive disorder (occurrence of cognitive disorder)

时间窗: Up to 10 years

The investigators will track for occurrence of cognitive disorder by follow-up surveys and annual record linkage to the population-based disease or death registry collected by the Shenzhen Center for Disease Control and Prevention, and Health Insurance Bureau. All cases will be verified by medical record reviews.

Diabetes mellitus

时间窗: Up to 10 years

The investigators will also track for occurrence of diabetes mellitus by follow-up surveys and annual record linkage to the population-based disease or death registry collected by the Shenzhen Center for Disease Control and Prevention and Health Insurance Bureau. All cases will be verified by medical record reviews.

Stroke (occurrence of stroke)

时间窗: Up to 10 years

The investigators will track for occurrence of stroke by follow-up surveys and annual record linkage to the population-based disease or death registry collected by the Shenzhen Center for Disease Control and Prevention, and Health Insurance Bureau. All cases will be verified by medical record reviews.

次要结局

  • Handgrip strength(Up to 10 years)
  • Metabolic syndrome(Up to 10 years)
  • Change lipid profile(Up to 10 years)
  • Usual gait speed(Up to 10 years)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yu-ming Chen

Professor

Sun Yat-sen University

研究点 (2)

Loading locations...

相似试验