A Comprehensive Longitudinal Cohort Study in Type 2 Diabetes With High Risk of Cardiovascular Diseases in China (CCMR-3B Ext)

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)

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes

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).

• Study Type: Observational
• Enrollment (Anticipated): 5000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
with CAD; Patients with hypertension and dyslipidemia with prior CAD
without CAD; Patients with hypertension and dyslipidemia without prior CAD

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Annual incidence of microvascular complications	3 years

Collaborators and Investigators

• Sponsor: China Cardiometabolic Registries
• Collaborators: Merck Sharp & Dohme LLC; Chinese Medical Doctor Association; China Gerontological Society; VitalStrategic Research Institute
• Investigators: Principal Investigator: Linong Ji, MD, People's Hospital, Beijing University; Principal Investigator: Dayi Hu, MD, People's Hospital, Beijing University

Publications and helpful links

Helpful Links

• Website for China Cardiometabolic Registries

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): May 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: March 1, 2011
• First Submitted That Met QC Criteria: March 1, 2011
• First Posted (Estimate): March 2, 2011

Study Record Updates

• Last Update Posted (Estimate): February 15, 2013
• Last Update Submitted That Met QC Criteria: February 13, 2013
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Patients with type 2 diabetes and participated in 3B Study
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CCMR-303-3B Extension