Nationwide Assessment of Cardiovascular Risk Factors: in Chinese Patients With Type 2 Diabetes (3B)

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Gerontological Society of China (GSC)
VitalStrategic Research Institute
Information provided by:
China Cardiometabolic Registries
ClinicalTrials.gov Identifier:
NCT01128205
First received: May 19, 2010
Last updated: June 14, 2011
Last verified: August 2010
  Purpose

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.

Condition
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
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)

Resource links provided by NLM:


Further study details as provided by China Cardiometabolic Registries:

Primary Outcome Measures:
  • 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. [ Time Frame: From the time of enrollment to within 30 day of enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 25000
Study Start Date: June 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diagnosed for 6 months or more

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Chinese type 2 diabetic out-patients with diagnosis for 6 months or more

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01128205

Locations
China
Peking Univresity People's Hospital
Beijing, China
Sponsors and Collaborators
China Cardiometabolic Registries
Merck Sharp & Dohme Corp.
Gerontological Society of China (GSC)
VitalStrategic Research Institute
Investigators
Principal Investigator: Linong Ji, MD Peking University People's Hospital
Principal Investigator: Dayi Hu, MD Peking University People's Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Li Nong Ji, MD, Peking Univeristy People's Hospital
ClinicalTrials.gov Identifier: NCT01128205     History of Changes
Other Study ID Numbers: CCMR-302-3B
Study First Received: May 19, 2010
Last Updated: June 14, 2011
Health Authority: China: Ministry of Health
China: Chinese Medical Doctor Association

Keywords provided by China Cardiometabolic Registries:
diabetes
cardiovascular risk factors
blood pressure
blood lipid
blood glucose

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 23, 2014