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

June 14, 2011 updated by: China Cardiometabolic Registries

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)

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

25000

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
      • Beijing, China
        • Peking Univresity People's Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Diagnosed for 6 months or more

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From the time of enrollment to within 30 day of enrollment

Collaborators and Investigators

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

Sponsor

China Cardiometabolic Registries

Collaborators

Merck Sharp & Dohme LLC
China Gerontological Society
VitalStrategic Research Institute

Investigators

  • Principal Investigator: Dayi Hu, MD, Peking University People's 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.

General Publications

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

June 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

May 19, 2010

First Submitted That Met QC Criteria

May 20, 2010

First Posted (Estimate)

May 21, 2010

Study Record Updates

Last Update Posted (Estimate)

June 15, 2011

Last Update Submitted That Met QC Criteria

June 14, 2011

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCMR-302-3B

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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