Cohort Study in Type 2 Diabetes in China (CCDC)

February 13, 2013 updated by: China Cardiometabolic Registries

Comprehensive Cohort Study in Type 2 Diabetes With High Risk of Cardiovascular Disease in China

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Weiqing Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Out patients of Tier 3 hospitals

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Outcomes of current anti-diabetic treatment
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Cardiometabolic Registries

Collaborators

Roche Pharma AG
VitalStrategic Research Institute
Chinese College of Cardiovascular Physicians
Chinese Society of Endocrinology

Investigators

  • Principal Investigator: Guang Ning, MD, Shanghai JiaoTong University Ruijing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

October 1, 2012

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

February 24, 2010

First Submitted That Met QC Criteria

February 24, 2010

First Posted (Estimate)

February 25, 2010

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 13, 2013

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCMR-301-CCDC
  • CCDC (Registry Identifier: CCMR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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