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

Type 2 Diabetes Clinical Trial

— CCMR-3B Ext  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01307410
• Other study ID #: CCMR-303-3B Extension
• Status: Active, not recruiting
• Phase: N/A
• First received: March 1, 2011
• Last updated: February 13, 2013
• Start date: March 2011
• Est. completion date: December 2014

Study information

• Verified date: February 2011
• Source: China Cardiometabolic Registries
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of HealthChina: Chinese Medical Doctor Association
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: December 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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,

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
China Cardiometabolic Registries	Chinese Medical Doctor Association, Gerontological Society of China, Merck Sharp & Dohme Corp., VitalStrategic Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of CVD events	The CVD event is defined as composite of : Acute myocardial infarction; Stroke; Cardiovascular death	3 years	No
Secondary	Annual incidence of microvascular complications		3 years	No

External Links

•   Website for China Cardiometabolic Registries