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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

Study Description
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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.

Condition or disease
Type 2 Diabetes

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 Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comprehensive Cohort Study in Type 2 Diabetes With High Risk of Cardiovascular Disease in China
Study Start Date : February 2010
Actual Primary Completion Date : October 2012
Estimated Study Completion Date : March 2013

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Outcomes of current anti-diabetic treatment [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Out patients of Tier 3 hospitals
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076023


Locations
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China, Shanghai
Weiqing Wang
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
China Cardiometabolic Registries
Roche Pharma AG
VitalStrategic Research Institute
Chinese College of Cardiovascular Physicians
Chinese Society of Endocrinology
Investigators
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Principal Investigator: Guang Ning, MD Shanghai JiaoTong University RuiJing Hospital
More Information
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Responsible Party: China Cardiometabolic Registries
ClinicalTrials.gov Identifier: NCT01076023    
Other Study ID Numbers: CCMR-301-CCDC
CCDC ( Registry Identifier: CCMR )
First Posted: February 25, 2010    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2010
Keywords provided by China Cardiometabolic Registries:
Diabetes
Cardiovascular disease
Observational study
China
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases