Cohort Study in Type 2 Diabetes in China (CCDC)

• ClinicalTrials.gov Identifier: NCT01076023
• Recruitment Status: Unknown
• First Posted: February 25, 2010
• Last Update Posted: February 15, 2013
• Sponsor: China Cardiometabolic Registries
• Collaborators: Roche Pharma AG; VitalStrategic Research Institute; Chinese College of Cardiovascular Physicians; Chinese Society of Endocrinology
• Information provided by (Responsible Party): China Cardiometabolic Registries

Tracking Information

• First Submitted Date: February 24, 2010
• First Posted Date: February 25, 2010
• Last Update Posted Date: February 15, 2013
• Study Start Date: February 2010
• Actual Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 5, 2010): 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. [ Time Frame: 12 months ]
• Original Primary Outcome Measures (submitted: February 24, 2010): Incidence of cardiovascular events, including fatal and non-fatal acute coronary syndromes (AMI or unstable angina), fatal or non-fatal stroke, and other cardiovascular death. [ Time Frame: 12 months ]
• Current Secondary Outcome Measures (submitted: February 24, 2010): Outcomes of current anti-diabetic treatment [ Time Frame: 12 months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cohort Study in Type 2 Diabetes in China
• Official Title: Comprehensive Cohort Study in Type 2 Diabetes With High Risk of Cardiovascular Disease in China
• 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.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Out patients of Tier 3 hospitals
• Condition: Type 2 Diabetes
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 24, 2010): 1000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2013
• Actual Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01076023
• Other Study ID Numbers: CCMR-301-CCDC; CCDC ( Registry Identifier: CCMR )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: China Cardiometabolic Registries
• Study Sponsor: China Cardiometabolic Registries

Collaborators

• Roche Pharma AG
• VitalStrategic Research Institute
• Chinese College of Cardiovascular Physicians
• Chinese Society of Endocrinology

Investigators

• Principal Investigator: Guang Ning, MD; Shanghai JiaoTong University RuiJing Hospital

• PRS Account: China Cardiometabolic Registries
• Verification Date: February 2010