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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
VitalStrategic Research Institute
Gerontological Society of China
Chinese Medical Doctor Association
Information provided by (Responsible Party):
China Cardiometabolic Registries
ClinicalTrials.gov Identifier:
NCT01307410
First received: March 1, 2011
Last updated: February 13, 2013
Last verified: February 2011
  Purpose

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
Type 2 Diabetes

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by China Cardiometabolic Registries:

Primary Outcome Measures:
  • Incidence of CVD events [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    The CVD event is defined as composite of :

    • Acute myocardial infarction
    • Stroke
    • Cardiovascular death


Secondary Outcome Measures:
  • Annual incidence of microvascular complications [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: March 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
with CAD
Patients with hypertension and dyslipidemia with prior CAD
without CAD
Patients with hypertension and dyslipidemia without prior CAD

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: China Cardiometabolic Registries
ClinicalTrials.gov Identifier: NCT01307410     History of Changes
Other Study ID Numbers: CCMR-303-3B Extension
Study First Received: March 1, 2011
Last Updated: February 13, 2013
Health Authority: China: Ministry of Health
China: Chinese Medical Doctor Association

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

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

ClinicalTrials.gov processed this record on July 26, 2014