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

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ClinicalTrials.gov Identifier: NCT01307410
Recruitment Status : Unknown
Verified February 2011 by China Cardiometabolic Registries.
Recruitment status was:  Active, not recruiting
First Posted : March 2, 2011
Last Update Posted : February 15, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
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 Design

Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : March 2011
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Incidence of CVD events [ Time Frame: 3 years ]

    The CVD event is defined as composite of :

    • Acute myocardial infarction
    • Stroke
    • Cardiovascular death


Secondary Outcome Measures :
  1. Annual incidence of microvascular complications [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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,
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01307410


Sponsors and Collaborators
China Cardiometabolic Registries
Merck Sharp & Dohme Corp.
VitalStrategic Research Institute
Gerontological Society of China
Chinese Medical Doctor Association
Investigators
Principal Investigator: Linong Ji, MD People's Hospital, Beijing University
Principal Investigator: Dayi Hu, MD People's Hospital, Beijing University
More Information

Additional Information:
Responsible Party: China Cardiometabolic Registries
ClinicalTrials.gov Identifier: NCT01307410     History of Changes
Other Study ID Numbers: CCMR-303-3B Extension
First Posted: March 2, 2011    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2011

Keywords provided by China Cardiometabolic Registries:
Patients with type 2 diabetes and participated in 3B Study

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases