A Comprehensive Longitudinal Cohort Study in Type 2 Diabetes With High Risk of Cardiovascular Diseases in China
CCMR-3B Ext
1 other identifier
observational
5,000
0 countries
N/A
Brief Summary
In 2010, the sponsor conducted an observational study, entitled as "Nationwide Assessment of Cardiovascular Risk Factors: Blood Pressure, Blood Lipid, and Blood Glucose, in Chinese Patients with Type 2 Diabetes - 3B Study " which was to evaluate the level of cardiovascular diseases (CVD) risk factor control and its regional difference in China. As a continuation, this extension of the 3B Study is designed to assess the incidence of cardiovascular events, cardio-renal events, and other microvascular complications, in 1, 2 and 3 years in patients with type 2 diabetes and with high risk of (CVD) with or without existing or history of coronary artery diseases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2011
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedFirst Posted
Study publicly available on registry
March 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFebruary 15, 2013
February 1, 2011
3.2 years
March 1, 2011
February 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of CVD events
The CVD event is defined as composite of : * Acute myocardial infarction * Stroke * Cardiovascular death
3 years
Secondary Outcomes (1)
Annual incidence of microvascular complications
3 years
Study Arms (2)
with CAD
Patients with hypertension and dyslipidemia with prior CAD
without CAD
Patients with hypertension and dyslipidemia without prior CAD
Eligibility Criteria
Patients with type 2 diabetes who previously participated in the 3B study from either community (tier 1), regional (tier 2), or teriary (tier 3) hospitals
You may qualify if:
- Age 40 years or older
You may not qualify if:
- With hypertension,dyslipidemia and one of the following:
- History of acute coronary artery disease or ischemic stroke
- Age \> 65 years old
- Overweight or obesity (BMI \> 24 kg/m2)
- Microalbuminuria or albuminuria
- Current smoker
- Patients with type 1 DM
- Pregnant or breast feeding women
- Patients who are unable to or not willing to return for follow up visits every 6 months for 3 years;
- Patients have severe heart failure (NYHA Class III-IV)
- Patients with severe renal deficiency (creatinine clearance \< 30 ml/min)
- Patients who are not willing to sing the informed consent form;
- Patients who are participating in any other interventional clinical studies,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- China Cardiometabolic Registrieslead
- Merck Sharp & Dohme LLCcollaborator
- VitalStrategic Research Institutecollaborator
- China Gerontological Societycollaborator
- Chinese Medical Doctor Associationcollaborator
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Linong Ji, MD
People's Hospital, Beijing University
- PRINCIPAL INVESTIGATOR
Dayi Hu, MD
People's Hospital, Beijing University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2011
First Posted
March 2, 2011
Study Start
March 1, 2011
Primary Completion
May 1, 2014
Study Completion
December 1, 2014
Last Updated
February 15, 2013
Record last verified: 2011-02