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

Risk Factors of Incidence of Type 2 Diabetes and Cardiovascular Diseases

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Disease; Type 2 Diabetes

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
• Enrollment (Anticipated): 3000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• aged above 40 years

Exclusion Criteria:

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Study Chair: Guang Ning, MD, PHD, Shanghai Clinical Centre for Endocrinology and Metabolism

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Anticipated): September 1, 2009
• Study Completion (Anticipated): September 1, 2009

Study Registration Dates

• First Submitted: July 29, 2009
• First Submitted That Met QC Criteria: July 29, 2009
• First Posted (Estimate): July 30, 2009

Study Record Updates

• Last Update Posted (Estimate): July 30, 2009
• Last Update Submitted That Met QC Criteria: July 29, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: genetic
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CCEMD007