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Cohort Study in Type 2 Diabetes in China (CCDC)

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ClinicalTrials.gov Identifier: NCT01076023
Recruitment Status : Unknown
Verified February 2010 by China Cardiometabolic Registries.
Recruitment status was:  Active, not recruiting
First Posted : February 25, 2010
Last Update Posted : February 15, 2013
Sponsor:
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 ]
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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