A Comprehensive Longitudinal Cohort Study in Type 2 Diabetes With High Risk of Cardiovascular Diseases in China (CCMR-3B Ext)
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition |
|---|
|
Type 2 Diabetes |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Comprehensive Longitudinal Cohort Study in Type 2 Diabetes With High Risk of Cardiovascular Diseases in China - 3B Extension A Study of China Cardiometabolic Registries (CCMR) |
- Incidence of CVD events [ Time Frame: 3 years ] [ Designated as safety issue: No ]
The CVD event is defined as composite of :
- Acute myocardial infarction
- Stroke
- Cardiovascular death
- Annual incidence of microvascular complications [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 5000 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
with CAD
Patients with hypertension and dyslipidemia with prior CAD
|
|
without CAD
Patients with hypertension and dyslipidemia without prior CAD
|
Detailed Description:
Limited by its cross sectional design, 3B study was not be able to provide any information on how various patterns of treatment and prescribing behaviors would impact the outcomes of prevention of cardiovascular and cardio-renal diseases in type 2 diabetes longitudinally. This information, however, would be crucial in better guiding the real world medical practice and maximizing the effectiveness of medical treatment for better controlling cardiovascular risk factors.
The 3B Extension study is thus designed to extend the 3B study by continuing to follow up on enrolled patients for 3 years. The 3B Extension study is expected to demonstrate the clinical outcomes of nationally representative type 2 diabetes patients who are treated by endocrinologists, cardiologists and nephrologists separately in all tiers of hospitals, as measured by diabetes progression, incidence of cardiovascular complications, and incidence of microvascular complications. It will be the first study of this scale in China based on its exclusivity, extensiveness, and the level of government and national thought leaders' support. It will be conducted in collaboration with the advisory board of China Cardiometabolic Registries (CCMR).
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
Inclusion Criteria:
- Age 40 years or older
- Outpatients who meet the inclusion and exclusion criteria of 3B study
- 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
Exclusion Criteria:
- 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,
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01307410
| Principal Investigator: | Linong Ji, MD | People's Hospital, Beijing University | |
| Principal Investigator: | Dayi Hu, MD | People's Hospital, Beijing University |
More Information
No publications provided
| Responsible Party: | China Cardiometabolic Registries |
| ClinicalTrials.gov Identifier: | NCT01307410 History of Changes |
| Other Study ID Numbers: | CCMR-303-3B Extension |
| Study First Received: | March 1, 2011 |
| Last Updated: | February 13, 2013 |
| Health Authority: | China: Ministry of Health China: Chinese Medical Doctor Association |
Keywords provided by China Cardiometabolic Registries:
|
Patients with type 2 diabetes and participated in 3B Study |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 |
Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on February 27, 2015