A Comprehensive Longitudinal Cohort Study in Type 2 Diabetes With High Risk of Cardiovascular Diseases in China

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)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01307410

Acronym

CCMR-3B Ext

Enrollment

5000

Registered

2011-03-02

Start date

2011-03-31

Completion date

2014-12-31

Last updated

2013-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Patients with type 2 diabetes and participated in 3B Study

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.

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of CVD events	3 years	The CVD event is defined as composite of : * Acute myocardial infarction * Stroke * Cardiovascular death

Secondary

Measure	Time frame
Annual incidence of microvascular complications	3 years

Outcome results