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Nanshan Elderly Cohort Study (NECS)

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ClinicalTrials.gov Identifier: NCT03569735
Recruitment Status : Recruiting
First Posted : June 26, 2018
Last Update Posted : June 26, 2018
Sponsor:
Collaborator:
Shenzhen Nanshan Center for Chronic Disease Control
Information provided by (Responsible Party):
Yu-ming Chen, Sun Yat-sen University

Brief Summary:

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:

    1. Blood tests: Metabolic syndrome-related indices; nutritional indices; inflammatory markers; sexual hormones; genetic markers.
    2. Urinary tests: Flavonoids and flavones, minerals, creatinine and renal function related markers.
    3. Fecal test: Gut microbiota and related metabolites.
  7. Morbidity and mortality: Relevant data will be also retrieved via local multiple Health information systems.
  8. Others: Many other laboratory tests or instrument tests will be developed depended on needs and resources in future.

Condition or disease
Hypertension Type 2 Diabetes Mellitus Cardiovascular Diseases Stroke Obesity Metabolic Syndrome Sarcopenia Chronic Kidney Disease Cancer Death

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nanshan Elderly Cohort Study:a Community-based Prospective Cohort Study in Nanshan, Shenzhen Residents
Actual Study Start Date : May 26, 2018
Estimated Primary Completion Date : December 30, 2028
Estimated Study Completion Date : December 30, 2028



Primary Outcome Measures :
  1. Diabetes mellitus [ Time Frame: 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.

  2. Cardiovascular diseases (occurrence of cardiovascular diseases) [ Time Frame: 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.

  3. Stroke (occurrence of stroke) [ Time Frame: 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.

  4. Cognitive disorder (occurrence of cognitive disorder) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Metabolic syndrome [ Time Frame: Up to 10 years ]
    The investigators will measure metabolic syndrome-related indices at each visit (per every 3 years), the investigators can analysis the incidence of metabolic syndrome.

  2. Change lipid profile [ Time Frame: Up to 10 years ]
    The investigators will measure fasting lipid profile (e.g., cholesterol, triglycerides, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol) at each visit, and analyse the change of these indices.

  3. Handgrip strength [ Time Frame: Up to 10 years ]
    The investigators will measure the handgrip strength, which will be used to diagnose sarcopenia according to definition recommended by Asian Working Group for Sarcopenia (AWGS): cutoff values for handgrip strength (<26 kg for men and <18 kg for women).

  4. Usual gait speed [ Time Frame: Up to 10 years ]
    The investigators will measure the usual gait speed., which will also be used to diagnose sarcopenia according to definition recommended by Asian Working Group for Sarcopenia (AWGS): cutoff values for usual gait speed (<0.8 m/s).


Biospecimen Retention:   Samples With DNA
Overnight fasting blood sample, early morning first-void urine sample and faeces samples will be collected at baseline and follow-up。


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The participants who meet the inclusion and exclusion criteria will be recruited from all communities of Nanshan, Shenzhen by face-to-face communication.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

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): NCT03569735


Contacts
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Contact: Yuming Chen 862087330605 chenyum@mail.sysu.edu.cn

Locations
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China, Guangdong
Department of Non-communicable Disease Prevention and Control, Shenzhen Nanshan Center for Chronic Disease Control Recruiting
Shenzhen, Guangdong, China, 518054
Contact: Changyi Wang, PhD    +86 15813830525    wangchangyi2002@163.com   
China
Department of Medical Statistics & Epidemiology, School of Public Health, Sun Yat-sen University Withdrawn
Guangzhou, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
Shenzhen Nanshan Center for Chronic Disease Control
Investigators
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Principal Investigator: Yuming Chen Sun Yat-sen University

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Responsible Party: Yu-ming Chen, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03569735     History of Changes
Other Study ID Numbers: 2017005
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Yu-ming Chen, Sun Yat-sen University:
Prospective Cohort Study
Nutrition
Chronic diseases
Nanshan
Chinese

Additional relevant MeSH terms:
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Metabolic Syndrome
Diabetes Mellitus
Cardiovascular Diseases
Kidney Diseases
Diabetes Mellitus, Type 2
Renal Insufficiency, Chronic
Sarcopenia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
Insulin Resistance
Hyperinsulinism
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms