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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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18 February 2013 |
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Main ID: |
NCT01076023 |
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Date of registration:
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24/02/2010 |
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Primary sponsor: |
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Public title:
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Cohort Study in Type 2 Diabetes in China
CCDC |
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Scientific title:
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Comprehensive Cohort Study in Type 2 Diabetes With High Risk of Cardiovascular Disease in China |
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Date of first enrolment:
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February 2010 |
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Target sample size:
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1000 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01076023 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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China
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Contacts
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Name:
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Guang Ning, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shanghai JiaoTong University RuiJing Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
40 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Outcomes of current anti-diabetic treatment
[Time Frame: 12 months]
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Secondary ID(s)
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CCDC
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CCMR-301-CCDC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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