Risk Factors of Incidence of Type 2 Diabetes and Cardiovascular Diseases---Shanghai Baoshan Study (SBSS)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT00949416
First received: July 29, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

Objective: Recruit 3 cohorts with 1000-1200 subjects each: people with normal glucose metabolism, impaired glucose regulation (IGR), and with Type 2 diabetes. To study the risk factors in development of type 2 diabetes.


Condition
Type 2 Diabetes
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors of Incidence of Type 2 Diabetes and Cardiovascular Diseases

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Estimated Enrollment: 3000
Study Start Date: June 2009
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Detailed Description:

Methods:

We aim to perform a two-step blood glucose survey in 2008-2009 in a population selected from a single urban community of Shanghai. The Institutional Review Board of the Rui-Jin Hospital approved the study protocol. Informed consent will be obtained from each participant.

  1. In the first step, we first invited all registered permanent residents aged 40 or above by local poster advertisement and by mail to participate in a screening examination, during which we collected information on lifestyle, medical history and the use of medications using a questionnaire, and performed anthropometrical measurements and fasting glucose measurement. The first step of diabetes screening finished in June, 2008.
  2. In the second step, after exclusion of subjects with self-reported diabetes, we classified the screened subjects into 3 groups according to their fasting plasma glucose concentration of 7.0 mmol/L or above, 5.0 to 6.9 mmol/L or below 5.0 mmol/L. We selected randomly a sample from these 3 subgroups for further investigation including a 75-g oral glucose tolerance test (OGTT) and blood and urine sampling and other vascular functional measurements. Our selection was based on a ratio of 1:1.2:1.44, because of the concern that by knowing the results of fasting plasma glucose test, subjects with lower glucose levels might have a lower participation rate than those with higher glucose concentrations. Nevertheless, this ratio was arbitrarily chosen. Finally, 1000 Type 2 diabetic patients, 1200 subjects with IGR and 1440 subjects with normal glucose metabolism were selected as target population of this study by random sampling for further blood and urine sampling.
  3. Biomarkers and genetic risk factors will be evaluated in the study subjects.
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

1000 Type 2 diabetic patients, 1200 subjects with IGR and 1440 subjects with normal glucose metabolism (aged above 40 years old, both men and women)were selected as target population of this study by random sampling.

Criteria

Inclusion Criteria:

  • aged above 40 years

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00949416

Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Study Chair: Guang Ning, MD, PHD Shanghai Clinical Centre for Endocrinology and Metabolism
  More Information

No publications provided

Responsible Party: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
ClinicalTrials.gov Identifier: NCT00949416     History of Changes
Other Study ID Numbers: CCEMD007
Study First Received: July 29, 2009
Last Updated: July 29, 2009
Health Authority: China: National Natural Science Foundation

Keywords provided by Shanghai Jiao Tong University School of Medicine:
genetic

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014