NCT01128205

Brief 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. 1.Proportion of patients reaching adequate control of blood glucose
  2. 2.Proportion of patients reaching adequate control of blood glucose and blood pressure, or blood glucose and blood lipid
  3. 3.Proportion of patients reaching adequate control of all 3Bs, i.e. blood glucose, blood pressure, and blood lipid.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2010

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 15, 2011

Status Verified

August 1, 2010

Enrollment Period

1 year

First QC Date

May 19, 2010

Last Update Submit

June 14, 2011

Conditions

Keywords

diabetescardiovascular risk factorsblood pressureblood lipidblood glucose

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Diagnosed for 6 months or more

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Outpatients with confirmed type 2 DM (According to ADA criteria) at least 6 month prior to the study visit;
  • At least 18 years or older;
  • 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;
  • Patients who are willing to sign consent form and are able to complete the questionnaires.

You may not qualify if:

  • Patients with type 1 DM;
  • Pregnant or breast feeding women;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Univresity People's Hospital

Beijing, China

Location

Related Publications (2)

  • Ji Q, Chai S, Zhang R, Li J, Zheng Y, Rajpathak S. Prevalence and co-prevalence of comorbidities among Chinese adult patients with type 2 diabetes mellitus: a cross-sectional, multicenter, retrospective, observational study based on 3B study database. Front Endocrinol (Lausanne). 2024 Jun 11;15:1362433. doi: 10.3389/fendo.2024.1362433. eCollection 2024.

  • Cai X, Ji L. Generalizability of the Results of Cardiovascular Outcome Trials of Glucagon-Like Peptide 1 Receptor Agonists in Chinese Patients with Type 2 Diabetes Mellitus. Diabetes Ther. 2021 Jul;12(7):1861-1870. doi: 10.1007/s13300-021-01079-x. Epub 2021 May 28.

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Linong Ji, MD

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR
  • Dayi Hu, MD

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

May 19, 2010

First Posted

May 21, 2010

Study Start

June 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

June 15, 2011

Record last verified: 2010-08

Locations