Cohort Study in Type 2 Diabetes in China

NCT ID: NCT01076023

Last Updated: 2013-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2013-03-31

Brief Summary

This study is designed to assess the incidence of cardiovascular events occurred within an 12 month follow up period in type 2 diabetic patients with either high risk of cardiovascular disease (CVD) or history of coronary artery disease (CAD) or stroke.

Detailed Description

The number of diabetes patients around the world has increased from 30 million in 1985 to the current 180 million, and is expected to grow to 366 million in 2025, with 75 percent occurring in developing countries such as India and China. In China, economic prosperity and changes in diet and lifestyles have resulted in steep increase in prevalence of overweight, obesity, and diabetes. Type 2 diabetes mellitus is associated with an increased risk for both micro-and macrovascular complications, and cardiovascular diseases (CVD) are the most common causes of death in these patients. Preventing the onset or the worsening of the cardiovascular diseases is thus one of the most important goals in managing type II diabetes. This study is designed to better understand the incidence of cardiovascular events under current patterns of treatment in type 2 diabetic patients with either 3 or more risk factors for cardiovascular disease such as older age, hypertension, dyslipidemia, etc, or existing or prior history of coronary artery disease and stroke. Approximately 1000 patients from major hospitals across several regions of China will be recruited for this study.

Conditions

Type 2 Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients who are 40 years of age or older
• Patients with confirmed diagnosis of type II diabetes
• Patients with 3 or more CVD risk factors or with confirmed/history of CAD or history of ischemic stroke
• Patients who have lab data within 30 days of baseline visit
• Patients who are willing to return for all follow up visits

Exclusion Criteria

• Patients who are not willing or not able to return to the same hospital within 12 months after enrollment
• Patients who have life threatening or terminal disease, or are physically unable to make follow up visits every 6 months after enrollment
• Patients have severe heart failure (New York Heart Association [NYHA] Class 3-4)
• Patients with severe renal deficiency (creatinine clearance less than 30 ml/min)
• Patients who are not willing to sign informed consent form

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

VitalStrategic Research Institute

OTHER

Sponsor Role: collaborator

Chinese College of Cardiovascular Physicians

UNKNOWN

Sponsor Role: collaborator

Chinese Society of Endocrinology

UNKNOWN

Sponsor Role: collaborator

China Cardiometabolic Registries

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guang Ning, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai JiaoTong University RuiJing Hospital

Locations

Weiqing Wang

Shanghai, Shanghai Municipality, China

Countries

China

Related Links

http://CCMRegistry.org

Related Info

Other Identifiers

CCDC

Identifier Type: REGISTRY

Identifier Source: secondary_id

CCMR-301-CCDC

Identifier Type: -

Identifier Source: org_study_id