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

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ClinicalTrials.gov Identifier: NCT00949416
Recruitment Status : Unknown
Verified July 2009 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Enrolling by invitation
First Posted : July 30, 2009
Last Update Posted : July 30, 2009
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine

Brief Summary:
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 or disease
Type 2 Diabetes Cardiovascular Disease

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.

Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors of Incidence of Type 2 Diabetes and Cardiovascular Diseases
Study Start Date : June 2009
Estimated Primary Completion Date : September 2009
Estimated Study Completion Date : September 2009

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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:   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:


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): 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

Responsible Party: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
ClinicalTrials.gov Identifier: NCT00949416     History of Changes
Other Study ID Numbers: CCEMD007
First Posted: July 30, 2009    Key Record Dates
Last Update Posted: July 30, 2009
Last Verified: July 2009

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

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