Cohort Study in Type 2 Diabetes in China (CCDC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by China Cardiometabolic Registries.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Roche Pharma AG
VitalStrategic Research Institute
Chinese College of Cardiovascular Physicians
China Endocrinologist Association
Information provided by (Responsible Party):
China Cardiometabolic Registries
ClinicalTrials.gov Identifier:
NCT01076023
First received: February 24, 2010
Last updated: February 13, 2013
Last verified: February 2010
  Purpose

This study is designed to assess the incidence of cardiovascular events occurred within an 12 month follow up period in type 2 diabetic patients with either high risk of cardiovascular disease (CVD) or history of coronary artery disease (CAD) or stroke.


Condition
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comprehensive Cohort Study in Type 2 Diabetes With High Risk of Cardiovascular Disease in China

Resource links provided by NLM:


Further study details as provided by China Cardiometabolic Registries:

Primary Outcome Measures:
  • Incidence of cardiovascular events, including fatal and non-fatal acute coronary syndromes (acute myocardial infarction [AMI] or unstable angina), fatal or non-fatal stroke, and other cardiovascular death. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Outcomes of current anti-diabetic treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: February 2010
Estimated Study Completion Date: March 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Detailed Description:

The number of diabetes patients around the world has increased from 30 million in 1985 to the current 180 million, and is expected to grow to 366 million in 2025, with 75 percent occurring in developing countries such as India and China. In China, economic prosperity and changes in diet and lifestyles have resulted in steep increase in prevalence of overweight, obesity, and diabetes. Type 2 diabetes mellitus is associated with an increased risk for both micro-and macrovascular complications, and cardiovascular diseases (CVD) are the most common causes of death in these patients. Preventing the onset or the worsening of the cardiovascular diseases is thus one of the most important goals in managing type II diabetes. This study is designed to better understand the incidence of cardiovascular events under current patterns of treatment in type 2 diabetic patients with either 3 or more risk factors for cardiovascular disease such as older age, hypertension, dyslipidemia, etc, or existing or prior history of coronary artery disease and stroke. Approximately 1000 patients from major hospitals across several regions of China will be recruited for this study.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Out patients of Tier 3 hospitals

Criteria

Inclusion Criteria:

  • Patients who are 40 years of age or older
  • Patients with confirmed diagnosis of type II diabetes
  • Patients with 3 or more CVD risk factors or with confirmed/history of CAD or history of ischemic stroke
  • Patients who have lab data within 30 days of baseline visit
  • Patients who are willing to return for all follow up visits

Exclusion Criteria:

  • Patients who are not willing or not able to return to the same hospital within 12 months after enrollment
  • Patients who have life threatening or terminal disease, or are physically unable to make follow up visits every 6 months after enrollment
  • Patients have severe heart failure (New York Heart Association [NYHA] Class 3-4)
  • Patients with severe renal deficiency (creatinine clearance less than 30 ml/min)
  • Patients who are not willing to sign informed consent form
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01076023

Locations
China, Shanghai
Weiqing Wang
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
China Cardiometabolic Registries
Roche Pharma AG
VitalStrategic Research Institute
Chinese College of Cardiovascular Physicians
China Endocrinologist Association
Investigators
Principal Investigator: Guang Ning, MD Shanghai JiaoTong University RuiJing Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: China Cardiometabolic Registries
ClinicalTrials.gov Identifier: NCT01076023     History of Changes
Other Study ID Numbers: CCMR-301-CCDC, CCDC
Study First Received: February 24, 2010
Last Updated: February 13, 2013
Health Authority: China: Ministry of Health

Keywords provided by China Cardiometabolic Registries:
Diabetes
Cardiovascular disease
Observational study
China

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 April 15, 2014