Clinical trial NCT01307410: A Comprehensive Longitudinal Cohort Study in Type 2 Diabetes With High Risk of Cardiovascular Diseases in China
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes
Keywords: Patients with type 2 diabetes and participated in 3B Study
Lead sponsor: China Cardiometabolic Registries
Sponsor class: NETWORK
Collaborators: name: Merck Sharp & Dohme LLC
name: VitalStrategic Research Institute
name: China Gerontological Society
name: Chinese Medical Doctor Association
First posted: 2011-03-02
Enrollment: 5000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

Eligibility criteria: 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,

Primary outcomes:
measure: Incidence of CVD events
timeFrame: 3 years
Secondary outcomes:
measure: Annual incidence of microvascular complications
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: People's Hospital, Beijing University
name: Linong Ji, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: People's Hospital, Beijing University
name: Dayi Hu, MD
role: PRINCIPAL_INVESTIGATOR
References: