Nationwide Assessment of Cardiovascular Risk Factors: in Chinese Patients With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— 3B  

Official title:

Nationwide Assessment of Cardiovascular Risk Factors: Blood Pressure, Blood Lipid, and Blood Glucose, in Chinese Patients With Type 2 Diabetes, A Study of China Cardiometabolic Registries (CCMR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01128205
• Other study ID #: CCMR-302-3B
• Status: Completed
• Phase: N/A
• First received: May 19, 2010
• Last updated: June 14, 2011
• Start date: June 2010
• Est. completion date: June 2011

Study information

• Verified date: August 2010
• Source: China Cardiometabolic Registries
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of HealthChina: Chinese Medical Doctor Association
• Study type: Observational

Clinical Trial Summary

The objective of this study is to evaluate the level of control of cardiovascular disease risk factors, including blood pressure, blood lipid, and blood glucose, in out patients with type 2 DM in 6 representative regions in China: Northeast, North, East, South, Southwest and Northwest, measured by,

1. Proportion of patients reaching adequate control of blood glucose

2. Proportion of patients reaching adequate control of blood glucose and blood pressure, or blood glucose and blood lipid

3. Proportion of patients reaching adequate control of all 3Bs, i.e. blood glucose, blood pressure, and blood lipid.

Description:

The prevalence of patients with diabetes mellitus (DM) worldwide has increased from 30 million in 1985 to 180 million at the present time. In China, the incidence of overweight, obesity, and DM has increased rapidly due to the significant change of diet and lifestyle resulted from rapid economic development. As estimated by International Diabetes Federation (IDF), the number of the patients with DM was about 39.8 million in China in 2007, and it is anticipated that the number would reach 59.3 million in 2025 [11]. At the same time there are a similar number of pre-diabetes patients with risk factors of cardiovascular diseases in China. DM and its associated microvascular and macrovascular complications could severely affects patients' quality of life and duration of survival and lead to significant increase in medical expenditure.

There have been a number of epidemiological surveys of diabetes conducted in other countries. However, there is little specific data available on the status of DM control and clinical outcomes of prevention and treatment of diabetic cardiovascular complications and other microvascular complications in China. This has made it difficult for clinicians to effectively make medical choices for patients with a variety of risk factors and complications.

This study is thus designed to assess the level of control of CVD risk factors, including blood pressure, blood lipid, and blood glucose, in outpatients with type 2 DM nation-wide across 6 representative regions in China: Northeast, North, East, South, Southwest and Northwest. The difference in clinical outcomes between the regions and between the three different tiers of hospitals, i.e. tier 3 (primary or teaching hospitals), tier 2 (secondary or city level hospitals), and tier 1 (community hospitals/health centers), will be made. The primary measurements include 1)Proportion of patients reaching adequate control of blood glucose (1B); 2)Proportion of patients reaching adequate control of blood glucose and blood pressure, or blood glucose and blood lipid (2B); and 3)Proportion of patients reaching adequate control of all 3Bs, i.e. blood glucose, blood pressure, and blood lipid. Other measurements include proportion of microvascular and macrovascular diabetic complications, DM treatment pattern and influence factors, physician prescribing behaviors, etc.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25000
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Outpatients with confirmed type 2 DM (According to ADA criteria) at least 6 month prior to the study visit;

2. At least 18 years or older;

3. Patients who are due and willing to receive a fasting blood testing within 7 days due to his/her underlying diseases, as determined by the investigator; or patients who have adequate blood test results obtained within 30 days;

4. Patients who are willing to sign consent form and are able to complete the questionnaires.

Exclusion Criteria:

1. Patients with type 1 DM;

2. Pregnant or breast feeding women;

3. Patients who are participating in any other clinical studies, including any questionnaire-based study, any interventional study (even diet/counseling based intervention), or any clinical trial in which any medication (including Chinese herbal medications) are administered.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Locations

Country	Name	City	State
China	Peking Univresity People's Hospital	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
China Cardiometabolic Registries	Gerontological Society of China (GSC), Merck Sharp & Dohme Corp., VitalStrategic Research Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion adequate control of blood glucose, blood glucose and blood pressure or blood glucose and blood lipid, and blood glucose, blood pressure and blood lipid.		From the time of enrollment to within 30 day of enrollment	No

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