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.
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
- Conditions the study is for
- Hypertension, Type 2 Diabetes Mellitus, Cardiovascular Diseases
- 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
- Withdrawn
Department of Medical Statistics & Epidemiology, School of Public Health, Sun Yat-sen University
Guangzhou, 510080
- Recruiting
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
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:
- 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.
- Physical examinations: Anthropometric measurements, blood pressure tests, handgrip strength, and usual gait speed.
- Ultrasonography examinations: Ultrasonography examination will be performed to determine carotid artery intima-media thickness and plaque, fatty liver.
- Electrocardiogram test: Electrocardiogram test is to obtain information about the structure and function of the heart.
- 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.
- Laboratory tests:
- Blood tests: Metabolic syndrome-related indices; nutritional indices; inflammatory markers; sexual hormones; genetic markers.
- Urinary tests: Flavonoids and flavones, minerals, creatinine and renal function related markers.
- Fecal test: Gut microbiota and related metabolites.
- Morbidity and mortality: Relevant data will be also retrieved via local multiple Health information systems.
- 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:
- 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);
- Physical examinations: Anthropometric measurements (weight, height, waist, hip and neck circumference, etc.), blood pressure tests, handgrip strength, and usual gait speed.
- 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.
- Electrocardiogram test: Electrocardiogram test is to obtain information about the structure and function of the heart.
- 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.
- Laboratory tests:
- 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;
- Nutritional indices: Serum concentrations of carotenoids, erythrocyte fatty acids, serum minerals, folate, betaine, choline, TMAO, and vitamin D, etc.
- Inflammatory markers (e.g., hsCRP, RBP4,IL-6, TNF-a)
- Sexual hormones (e.g., testosterone, SHBG)
- Genetic markers
- Urinary tests: Flavonoids and flavones, minerals, creatinine and renal function related markers.
- Fecal test: Gut microbiota and related metabolites.
- Morbidity and mortality: Relevant data will be also retrieved via local multiple Health information systems.
- 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.
- Conditions
- Hypertension, Type 2 Diabetes Mellitus, Cardiovascular Diseases, Stroke, Obesity, Metabolic Syndrome
- 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.
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
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
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
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)
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
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
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
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.
- First posted26 Jun 2018
- Study start26 May 2018
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Nanshan Center for Chronic Disease Control
- Responsible party
- Principal investigator, Yu-ming Chen, Sun Yat-sen University
- Investigators
- Yuming Chen, Principal investigator, Sun Yat-sen University
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nanshan Elderly Cohort Study:a Community-based Prospective Cohort Study in Nanshan, Shenzhen Residents
- ClinicalTrials.gov ID
- NCT03569735
- Acronym / sponsor ID
- NECS / 2017005
- Conditions
- Hypertension, Type 2 Diabetes Mellitus, Cardiovascular Diseases, Stroke, Obesity, Metabolic Syndrome
- Keywords
- Prospective Cohort Study, Nutrition, Chronic diseases, Nanshan, Chinese
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Shenzhen Nanshan Center for Chronic Disease Control
- Study start
- 26 May 2018 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Physical examinations: Anthropometric measurements, blood pressure tests, handgrip strength, and usual gait speed.
- Ultrasonography examinations: Ultrasonography examination will be performed to determine carotid artery intima-media thickness and plaque, fatty liver.
- Electrocardiogram test: Electrocardiogram test is to obtain information about the structure and function of the heart.
- 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.
- Laboratory tests:
- Blood tests: Metabolic syndrome-related indices; nutritional indices; inflammatory markers; sexual hormones; genetic markers.
- Urinary tests: Flavonoids and flavones, minerals, creatinine and renal function related markers.
- Fecal test: Gut microbiota and related metabolites.
- Morbidity and mortality: Relevant data will be also retrieved via local multiple Health information systems.
- Others: Many other laboratory tests or instrument tests will be developed depended on needs and resources in future.
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:
- 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);
- Physical examinations: Anthropometric measurements (weight, height, waist, hip and neck circumference, etc.), blood pressure tests, handgrip strength, and usual gait speed.
- 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.
- Electrocardiogram test: Electrocardiogram test is to obtain information about the structure and function of the heart.
- 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.
- Laboratory tests:
- 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;
- Nutritional indices: Serum concentrations of carotenoids, erythrocyte fatty acids, serum minerals, folate, betaine, choline, TMAO, and vitamin D, etc.
- Inflammatory markers (e.g., hsCRP, RBP4,IL-6, TNF-a)
- Sexual hormones (e.g., testosterone, SHBG)
- Genetic markers
- Urinary tests: Flavonoids and flavones, minerals, creatinine and renal function related markers.
- Fecal test: Gut microbiota and related metabolites.
- Morbidity and mortality: Relevant data will be also retrieved via local multiple Health information systems.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- Age: ≥ 65 years;
- Living in Nanshan, Shenzhen for at least 5 years;
- Chinese.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
Metabolic syndrome
Time frame: Up to 10 years
Change lipid profile
Time frame: Up to 10 years
Handgrip strength
Time frame: Up to 10 years
Usual gait speed
Time frame: Up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuming Chen principal investigator
Sun Yat-sen University
2 sites in 1 country: see every site and its status.
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.