Cohort Study in Type 2 Diabetes in China

Type 2 Diabetes Clinical Trial

— CCDC  

Official title:

Comprehensive Cohort Study in Type 2 Diabetes With High Risk of Cardiovascular Disease in China

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01076023
• Other study ID #: CCMR-301-CCDC
• Secondary ID: CCDC
• Status: Active, not recruiting
• Phase: N/A
• First received: February 24, 2010
• Last updated: February 13, 2013
• Start date: February 2010
• Est. completion date: March 2013

Study information

• Verified date: February 2010
• Source: China Cardiometabolic Registries
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: March 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Locations

Country	Name	City	State
China	Weiqing Wang	Shanghai	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
China Cardiometabolic Registries	China Endocrinologist Association, Chinese College of Cardiovascular Physicians, Roche Pharma AG, VitalStrategic Research Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cardiovascular events, including fatal and non-fatal acute coronary syndromes (acute myocardial infarction [AMI] or unstable angina), fatal or non-fatal stroke, and other cardiovascular death.		12 months	No
Secondary	Outcomes of current anti-diabetic treatment		12 months	No

External Links

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