Type 2 DiabetesCCDCNCT01076023
Cohort Study in Type 2 Diabetes in China
An observational study of Type 2 Diabetes, run by China Cardiometabolic Registries at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Feb 2010to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Out patients of Tier 3 hospitals
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, Cardiovascular disease, Observational study, China
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
Outcomes of current anti-diabetic treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionOct 2012
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Cardiometabolic Registries
- Sponsor type
- Research network
- Collaborators
- Roche Pharma AG, VitalStrategic Research Institute, Chinese College of Cardiovascular Physicians, Chinese Society of Endocrinology
- Responsible party
- Sponsor
- Investigators
- Guang Ning, MD, Principal investigator, Shanghai JiaoTong University RuiJing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076023
- Sponsor's protocol ID
- CCMR-301-CCDC
- Other IDs
- CCDC
- Acronym
- CCDC
- Status last verified
- Feb 2010
- First submitted
- 24 Feb 2010
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Cohort Study in Type 2 Diabetes With High Risk of Cardiovascular Disease in China
- ClinicalTrials.gov ID
- NCT01076023
- Acronym / sponsor ID
- CCDC / CCMR-301-CCDC
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, Cardiovascular disease, Observational study, China
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- China Cardiometabolic RegistriesResearch network
- Collaborators
- Roche Pharma AG, VitalStrategic Research Institute, Chinese College of Cardiovascular Physicians, Chinese Society of Endocrinology
- Study start
- Feb 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Mar 2013 (estimated)
- First posted
- 25 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Out patients of Tier 3 hospitals
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Outcomes of current anti-diabetic treatment
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guang Ning, MD principal investigator
Shanghai JiaoTong University RuiJing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by China Cardiometabolic Registries at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2013.