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

NCT ID: NCT01307410

Last Updated: 2013-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-12-31

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).

Conditions

Type 2 Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

with CAD

Patients with hypertension and dyslipidemia with prior CAD

No interventions assigned to this group

without CAD

Patients with hypertension and dyslipidemia without prior CAD

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age 40 years or older

Exclusion Criteria

• 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,

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

VitalStrategic Research Institute

OTHER

Sponsor Role: collaborator

China Gerontological Society

OTHER

Sponsor Role: collaborator

Chinese Medical Doctor Association

OTHER

Sponsor Role: collaborator

China Cardiometabolic Registries

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linong Ji, MD

Role: PRINCIPAL_INVESTIGATOR

People's Hospital, Beijing University

Dayi Hu, MD

Role: PRINCIPAL_INVESTIGATOR

People's Hospital, Beijing University

Related Links

http://www.CCMRegistry.org

Website for China Cardiometabolic Registries

Other Identifiers

CCMR-303-3B Extension

Identifier Type: -

Identifier Source: org_study_id