Risk Factors of Incidence of Type 2 Diabetes and Cardiovascular Diseases---Shanghai Baoshan Study (SBSS)
|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
|Condition or disease|
|Type 2 Diabetes Cardiovascular Disease|
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.
- 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.
- 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.
- Biomarkers and genetic risk factors will be evaluated in the study subjects.
|Study Type :||Observational|
|Estimated Enrollment :||3000 participants|
|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|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00949416
|Study Chair:||Guang Ning, MD, PHD||Shanghai Clinical Centre for Endocrinology and Metabolism|