Type 2 DiabetesCCMR-3B ExtNCT01307410
A Comprehensive Longitudinal Cohort Study in Type 2 Diabetes With High Risk of Cardiovascular Diseases in China
An observational study of Type 2 Diabetes, run by China Cardiometabolic Registries.
Trial 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… 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
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Dec 2014
- 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: 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
Who may be able to join
- 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
Who cannot join
- 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,
About this study
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)
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.
Read the 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).
- Conditions
- Type 2 Diabetes
- Keywords
- Patients with type 2 diabetes and participated in 3B Study
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| with CAD | Patients with hypertension and dyslipidemia with prior CAD | |
| without CAD | Patients with hypertension and dyslipidemia without prior CAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CVD events
The CVD event is defined as composite of :
- Acute myocardial infarction
- Stroke
- Cardiovascular death
Measured: 3 years
Secondary outcomes (1)
Annual incidence of microvascular complications
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2014 (estimated)
- Study completionDec 2014 (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
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Cardiometabolic Registries
- Sponsor type
- Research network
- Collaborators
- Merck Sharp & Dohme LLC, VitalStrategic Research Institute, China Gerontological Society, Chinese Medical Doctor Association
- Responsible party
- Sponsor
- Investigators
- Linong Ji, MD, Principal investigator, People's Hospital, Beijing UniversityDayi Hu, MD, Principal investigator, People's Hospital, Beijing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307410
- Sponsor's protocol ID
- CCMR-303-3B Extension
- Acronym
- CCMR-3B Ext
- Status last verified
- Feb 2011
- First submitted
- 1 Mar 2011
- 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
- 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)
- ClinicalTrials.gov ID
- NCT01307410
- Acronym / sponsor ID
- CCMR-3B Ext / CCMR-303-3B Extension
- Conditions
- Type 2 Diabetes
- Keywords
- Patients with type 2 diabetes and participated in 3B Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- China Cardiometabolic RegistriesResearch network
- Collaborators
- Merck Sharp & Dohme LLC, VitalStrategic Research Institute, China Gerontological Society, Chinese Medical Doctor Association
- Study start
- Mar 2011
- Primary completion
- May 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 2 Mar 2011 (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.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with CAD | – | –Patients with hypertension and dyslipidemia with prior CAD |
| without CAD | – | –Patients with hypertension and dyslipidemia without prior CAD |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
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 CVD events
Time frame: 3 years
The CVD event is defined as composite of : * Acute myocardial infarction * Stroke * Cardiovascular death
1 secondary outcome
Annual incidence of microvascular complications
Time frame: 3 years
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.
- Website for China Cardiometabolic RegistriesLink 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.
Linong Ji, MD principal investigator
People's Hospital, Beijing University
Dayi Hu, MD principal investigator
People's Hospital, Beijing University
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by China Cardiometabolic Registries.
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 8 inclusion and 7 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.
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 CVD events (time frame: 3 years). 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.