Nanshan Elderly Cohort Study

NCT03569735 | Recruiting

• 1 other identifier: 2017005
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 2

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. 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. 2.Physical examinations: Anthropometric measurements, blood pressure tests, handgrip strength, and usual gait speed.
3. 3.Ultrasonography examinations: Ultrasonography examination will be performed to determine carotid artery intima-media thickness and plaque, fatty liver.
4. 4.Electrocardiogram test: Electrocardiogram test is to obtain information about the structure and function of the heart.
5. 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. 6.Laboratory tests:
7. 7.Blood tests: Metabolic syndrome-related indices; nutritional indices; inflammatory markers; sexual hormones; genetic markers.
8. 8.Urinary tests: Flavonoids and flavones, minerals, creatinine and renal function related markers.
9. 9.Fecal test: Gut microbiota and related metabolites.
10. 10.Morbidity and mortality: Relevant data will be also retrieved via local multiple Health information systems.
11. 11.Others: Many other laboratory tests or instrument tests will be developed depended on needs and resources in future.

Conditions

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

Keywords

Prospective Cohort Study; Nutrition; Chronic diseases; Nanshan; Chinese

Outcome Measures

Primary Outcomes (4)

• Diabetes mellitus

  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.

  Up to 10 years

• Cardiovascular diseases (occurrence of cardiovascular diseases)

  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.

  Up to 10 years

• Stroke (occurrence of stroke)

  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.

  Up to 10 years

• Cognitive disorder (occurrence of cognitive disorder)

  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.

  Up to 10 years

Secondary Outcomes (4)

• Metabolic syndrome

  Up to 10 years

• Change lipid profile

  Up to 10 years

• Handgrip strength

  Up to 10 years

• Usual gait speed

  Up to 10 years

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Shenzhen Nanshan Center for Chronic Disease Control: collaborator

Study Sites (2)

Department of Non-communicable Disease Prevention and Control, Shenzhen Nanshan Center for Chronic Disease Control

Shenzhen, Guangdong, 518054, China

RECRUITING

Department of Medical Statistics & Epidemiology, School of Public Health, Sun Yat-sen University

Guangzhou, 510080, China

WITHDRAWN

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。

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2; Cardiovascular Diseases; Stroke; Obesity; Metabolic Syndrome; Sarcopenia; Renal Insufficiency, Chronic; Neoplasms; Death; Chronic Disease

Condition Hierarchy (Ancestors)

Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes

Study Officials

• Yuming Chen

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuming Chen

CONTACT

862087330605; chenyum@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 26, 2018
• Study Start: May 26, 2018
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: June 26, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)