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HypertensionNECSNCT03569735

Nanshan Elderly Cohort Study

An observational study of Hypertension and Type 2 Diabetes Mellitus, run by Sun Yat-sen University at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
How many people
20,000 participants
Where
2 sitesChina
Study dates
26 May 2018to 30 Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

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.

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China2 sites, 1 recruiting
  • Department of Medical Statistics & Epidemiology, School of Public Health, Sun Yat-sen University

    Guangzhou, 510080

    Withdrawn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

    Shenzhen, Guangdong, 518054

    Changyi Wang, PhD, +86 15813830525, wangchangyi2002@163.com

    Recruiting

Other trials in China

About this study

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

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.

Read more

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.
Read the detailed description

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:
  7. Metabolic syndrome-related indices: Fasting serum lipid profile (e.g., cholesterol, triglycerides, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol), diabetes-related indices (e.g., glucose, glycated hemoglobin, fructosamine and insulin), uric acid and creatinine;
  8. Nutritional indices: Serum concentrations of carotenoids, erythrocyte fatty acids, serum minerals, folate, betaine, choline, TMAO, and vitamin D, etc.
  9. Inflammatory markers (e.g., hsCRP, RBP4,IL-6, TNF-a)
  10. Sexual hormones (e.g., testosterone, SHBG)
  11. Genetic markers
  12. Urinary tests: Flavonoids and flavones, minerals, creatinine and renal function related markers.
  13. Fecal test: Gut microbiota and related metabolites.
  14. Morbidity and mortality: Relevant data will be also retrieved via local multiple Health information systems.
  15. Others: Many other laboratory tests or instrument tests will be developed depended on needs and resources in future.

Statistical analysis: Cox proportional hazards models or logistic regression models will be used to estimate the risk of exposures on categorical outcomes. Path analysis also will be used to assess the potential mediating effects in the causal pathway between exposures and outcomes.

Keywords
Prospective Cohort Study, Nutrition, Chronic diseases, Nanshan, Chinese
Medical subject headings
Hypertension, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Stroke, Obesity, Metabolic Syndrome, Sarcopenia, Renal Insufficiency, Chronic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 10 years

  2. 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.

    Measured: Up to 10 years

  3. 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.

    Measured: Up to 10 years

  4. 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.

    Measured: Up to 10 years

Secondary outcomes (4)
  1. Metabolic syndrome

    The investigators will measure metabolic syndrome-related indices at each visit (per every 3 years), the investigators can analysis the incidence of metabolic syndrome.

    Measured: Up to 10 years

  2. Change lipid profile

    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.

    Measured: Up to 10 years

  3. Handgrip strength

    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).

    Measured: Up to 10 years

  4. Usual gait speed

    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).

    Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2018
  2. Study start26 May 2018
  3. Primary completion30 Dec 2028 (estimated)
  4. Study completion30 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03569735
Sponsor's protocol ID
2017005
Acronym
NECS
Status last verified
Jun 2018
First submitted
22 May 2018
Last updated
26 Jun 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension and Type 2 Diabetes Mellitus, run by Sun Yat-sen University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yuming Chen (862087330605, chenyum@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diabetes mellitus (time frame: Up to 10 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.

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