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Guangzhou Nutrition and Health Study (GNHS) (GNHS)

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ClinicalTrials.gov Identifier: NCT03179657
Recruitment Status : Active, not recruiting
First Posted : June 7, 2017
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Yu-ming Chen, Sun Yat-sen University

Brief Summary:

Purpose: The Guangzhou Nutrition and Health Study (GNHS) aims to assess the determinants of risk of osteoporosis and cardio-metabolic diseases and changes in their relevant indices in nutritional aspects, as well as other environmental and genetic factors.

Study design: GNHS is a community-based prospective cohort study.

Participants: About 4048 apparently healthy residents, living in Guangzhou city (South China) for >5 years, aged 40-80 years, recruited between 2008 and 2013.

Visits and Data Collection: Participants were/will be visited every three years by invited to the School of Public Health, Sun Yat-sen University. At each visit, face-to-face interviews, specimen collection, anthropometric measurements, DXA scanning, ultrasonography evaluation were/will be conducted. Up to May 2017, 3143 and 2312 subjects completed the 2nd and 3rd visits.

Key variables:

  1. Questionnaire interviews: Structured questionnaires were/will be used to collect the participants' socio-demographic characteristics, lifestyle factors, menstruation and reproductive history (women only), sleep quality, family history, psychological health, social support and participation, cognitive function, habitual dietary intake, use of supplements and history of chronic diseases.
  2. Physical examinations: Anthropometric measurements, blood pressure tests, handgrip strength, and usual gait speed.
  3. DXA scanning: A dual-energy x-ray absorptiometry (DXA) was/will be used to determine bone density and bone mineral content, bone geometry information, fat mass and muscle mass.
  4. Ultrasonography evaluations: Ultrasonography evaluation was/will be performed to determine carotid artery intima-media thickness and plaque, and fatty liver.
  5. Specimen collections: Overnight fasting blood sample and early morning first-void urine sample and faces samples were/will be collected, separated and stored at −80°C till tests.
  6. Laboratory tests:

    1. Blood tests: Metabolic syndrome-related indices; inflammatory markers; sexual hormones and SHBG; genetic markers; nutritional indices (e.g., carotenoids; fatty acids; minerals, folate, betaine, choline, and vitamin D, etc.)
    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 were/will be also retrieved via local multiple health information systems.

Condition or disease
Cardiovascular Diseases Osteoporosis Diabetes Mellitus, Type 2 Obesity Hypertension Chronic Kidney Disease Chronic Disease Cancer Death Nutrition Disorders Metabolic Syndrome Sarcopenia

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Detailed Description:

Purpose: The Guangzhou Nutrition and Health Study (GNHS) aims to assess the determinants of risk of osteoporosis and cardio-metabolic diseases and changes in their relevant indices (e.g., osteoporosis, atherosclerosis, type 2 diabetes, hypertension, metabolic syndrome, non-alcoholic fatty liver disease, cardiovascular diseases, chronic kidney disease, body composition, etc.) in nutritional aspects, as well as other environmental and genetic factors.

Study design: GNHS is a community-based prospective cohort study.

Participants: About 4048 apparently healthy residents, living in Guangzhou city (South China) for >5 years, aged 40-80 years, recruited between 2008 and 2013.

Visits and Data Collection: Participants were/will be visited every three years by invited to the School of Public Health, Sun Yat-sen University. At each visit, face-to-face interviews, specimen collection, anthropometric measurements, DXA scanning, ultrasonography evaluation were/will be conducted. Up to May 2017, 3143 subjects completed their 2nd visits, and 2312 attended their 3rd visits. It is planned to follow up the participant in person for at least 15 years.

Key variables:

  1. Questionnaire interviews: Structured questionnaires were/will be used to collect the participants' socio-demographic characteristics (e.g., age, sex and household income), lifestyle factors (smoking, passive smoking, alcohol drinking, tea drinking, physical activity), menstruation and reproductive history (women only), sleep quality (Pittsburgh Sleep Quality Index, PSQI), family history, psychological health (Self-Rating Anxiety Scale, SAS), social support and participation, cognitive function (Mini-Mental State Examinations, MMSE), habitual dietary intake (a validated 79-item quantitative food frequency questionnaire), use of supplements and history of chronic diseases.
  2. Physical examinations: Anthropometric measurements (weight, height, waist, hip and neck circumference, etc.), blood pressure tests, handgrip strength, and usual gait speed.
  3. DXA scanning: A dual-energy x-ray absorptiometry (DXA, Discovery W; Hologic Inc.) was/will be used to determine bone density and bone mineral content at the whole body, lumbar spine (L1-L4), left hip sites, bone geometry information at the hip, fat mass and muscle mass at total body and its sub-regions.
  4. Ultrasonography evaluations: Ultrasonography evaluation of the carotid artery and upper abdominal organs (e.g., liver and kidney) was/will be performed to determine carotid artery intima-media thickness and plaque, fatty liver.
  5. Specimen collections: Overnight fasting blood sample was/will be collected and separated into serum, plasma, erythrocyte and leukocyte within two hours. Early morning first-void urine sample and faces samples were/will be collected. All specimens were/will separated and stored at −80°C till tests.
  6. Laboratory tests:

    1. Metabolic syndrome-related indices: Fasting serum lipid profile, diabetes-related indices, uric acid and creatinine;
    2. Nutritional indices: Serum concentrations of carotenoids, erythrocyte fatty acids, serum minerals, folate, betaine, choline, TMAO, and vitamin D, etc.
    3. Inflammatory markers (e.g., CRP, RBP4,IL-6, TNF-a)
    4. Sexual hormones, SHBG
    5. Genetic markers
    6. Urinary tests: Flavonoids and flavones, minerals, creatinine and renal function related markers
    7. Fecal test: Gut microbiota and related metabolites.
  7. Morbidity and mortality: Relevant data were/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.

Data analysis: Analyses of variance and covariance, or mixed effects model were/will be used to compare the mean differences in continuous outcomes (e.g., changes of bone mineral density, body fat mass, or intima-media thickness) among the quartiles. Cox proportional hazards or logistic regression models were/will be used to assess the risk of exposures (e.g., nutrition intakes and physical activity) on categorical outcomes. Path analysis was/will be used to assess the potential mediating effects in the causal pathway between exposures and outcomes.


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Study Type : Observational
Actual Enrollment : 4540 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Guangzhou Nutrition and Health Study (GNHS): a Community-based Prospective Cohort Study in Guangzhou Residents
Actual Study Start Date : July 1, 2008
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2027



Primary Outcome Measures :
  1. Cardiovascular diseases (change in carotid artery intima-media thickness, and occurrence of cardiovascular diseases) [ Time Frame: Up to 15 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 Guangzhou Center for Disease Control and Prevention, and Health Insurance Bureau. All cases will be verified by medical record reviews. The investigators will also measure the carotid artery intima-media thickness at each visit (per every 3 years),and analyse the change of carotid artery intima-media thickness.

  2. Bone health (change of bone mineral density, and occurrence of osteoporosis and fractures) [ Time Frame: Up to 12 years ]
    The investigators will measure the bone mineral density at each follow-up, and osteoporosis was defined as T-score ≤ −2.5 in accordance with the WHO criteria. The investigators will also track for occurrence of osteoporosis and fractures by follow-up surveys and annual record linkage to the population-based disease or death registration collected by the Guangzhou Center for Disease Control and Prevention, and Health Insurance Bureau. All cases will be verified by medical record reviews. Moreover, the investigators will analysis the annual change of bone mineral density.

  3. Nonalcoholic fatty liver disease (NAFLD) [ Time Frame: Up to 12 years ]
    The investigators will measure the abdominal ultrasonography at each follow-up and NAFLD was diagnosed based on standard criteria issued by the Fatty Liver Disease Study Group of the Chinese Liver Disease Association. The investigators will also track for occurrence of NAFLD by follow-up surveys and annual record linkage to the population-based disease or death registry collected by the Guangzhou Center for Disease Control and Prevention and Health Insurance Bureau. All cases will be verified by medical record reviews.


Secondary Outcome Measures :
  1. Change in adiposity-related indices [ Time Frame: Up to 9 years ]
    The investigators will measure the anthropometric indices at each visit and DXA-derived body fat composition since the 2nd visit.And the investigators will also analysis the change of adiposity-related indices.

  2. Metabolic syndrome [ Time Frame: Up to 15 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,and the changes of the individual items.

  3. Change in muscle mass [ Time Frame: Up to 12 years ]
    The investigators will measure the DXA-derived body muscle since Visit 2. And the investigators will also analysis the change of adiposity-related indices.

  4. Sarcopenia [ Time Frame: Up to 12 years ]
    The investigators will measure the handgrip strength, usual gait speed, and DXA-derived body muscle since Visit 2. The sarcopenia will be diagnosed according to definition recommended by Asian Working Group for Sarcopenia (AWGS): cutoff values for muscle mass measurements (7.0 kg/m2 for men and 5.4 kg/m2 for women by using dual X-ray absorptiometry, and 7.0 kg/m2 for men and 5.7 kg/m2 for women by using bioimpedance analysis), handgrip strength (<26 kg for men and <18 kg for women), and usual gait speed (<0.8 m/s).

  5. Diabetes mellitus (change of diabetic indices) [ Time Frame: Up to 15 years ]
    The investigators will measure the blood glucose, insulin, HbA1C. 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 Guangzhou Center for Disease Control and Prevention and Health Insurance Bureau. All cases will be verified by medical record reviews. Moreover, the investigators also will analysis the annual change of blood glucose and other diabetic indices.

  6. Cancer [ Time Frame: Up to 15 years ]
    The investigators will track for cancer occurrence by follow-up surveys and annual record linkage to the population-based disease or death registry collected by the Guangzhou Center for Disease Control and Prevention and Health Insurance Bureau. All cases will be verified by medical record reviews.

  7. Chronic kidney disease (CKD) [ Time Frame: Up to 12 years ]
    The investigators will measure the serum creatine and urine creatine and protein at baseline and each follow-up and CKD will be defined as an estimated glomerular filtration rate of <60 mL/min/1.73 m2 or and the presence of an elevated urine microalbumin/creatinine ratio. The investigators will also track for occurrence of CKD by follow-up surveys and annual record linkage to the population-based disease or death registry collected by the Guangzhou Center for Disease Control and Prevention and Health Insurance Bureau. All cases will be verified by medical record review.


Biospecimen Retention:   Samples With DNA
12-h fasting venous blood, urine and faeces was/will be collected at baseline and follow-ups.


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The participants were recruited from multiple communities covered the majority of Guangzhou city via the following measures: local advertisements, health talks, and referrals. The sample consisted of 68.0% women. At baseline, the mean age was 59 ± 6 years (women: 58 ± 5.7 years; men: 61 ± 7.0 years). 68% and 25% of them had education levels of secondary school and high school or above. 90% were married and 12% were smoker. Among women, 91% were menopausal. Mean BMI were 23 and 24 kg/m2 in women and men, respectively. Up to May 2017, 4540 participants attended baseline survey, 3400 and 2380 subjects completed the 2nd and 3rd visits. The whole cohort is planned to be followed at least 15 years.
Criteria

Inclusion Criteria:

  • Age: 40-80 years at baseline;
  • Living in Guangzhou for at least five years;
  • Chinese.

Exclusion Criteria:

  • Had a history of hospital-confirmed diabetes, failure(s) of heart, liver, or kidney, cancer, CVD events, metabolic bone diseases, glucocorticoid use (over 3 mo.) or sexual hormone use (over 6 mo.), spine or hip fractures;
  • 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): NCT03179657


Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Yuming Chen Sun Yat-sen University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yu-ming Chen, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03179657     History of Changes
Other Study ID Numbers: 2007032
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 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
Diet
Guangzhou
Chinese

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