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NCT01264263 Clinical Trial

Prevalence of Subclinical Atherosclerosis and Its Associated Factors in Hyperlipidemic Korean Adults With Diabetes

Diabetes Mellitus Clinical Trial

— ALTO  

Official title:
Prevalence of Subclinical Atherosclerosis and Its Associated Factors in Hyperlipidemic Korean Adults With Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01264263
Other study ID # NIS-CKR-DUM-2010/1
Secondary ID
Status Completed
Phase N/A
First received December 17, 2010
Last updated March 12, 2012
Start date January 2011
Est. completion date April 2011

Study information
Verified date March 2012
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Observational

Clinical Trial Summary

This study is to investigate correlation between Carotid Intima Media Thickness (cIMT) and several factors such as; hs C-reactive protein (CRP), HbA1c, lipid profile in Korean diabetic patients with atherosclerosis. Total 360 patients will be enrolled through 6 sites.

Description:

MC MD

Recruitment information / eligibility
Status Completed
Enrollment 181
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- patients with Diabetic Mellitus

- patients with dyslipidemia

Exclusion Criteria:

- patients who have established cardiovascular disease

- patient using NSAID

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Research Site Anyang
Korea, Republic of Research Site Koyang
Korea, Republic of Research Site Seoul

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measurement of intima media thickness, visit 1 Visit 1 No
Primary Measurement of intima media thickness, visit 2 Visit 2 No
Secondary hs-C-Reactive Protein, visit 1 Visit 1 No
Secondary hs-C-Reactive Protein, visit 2 Visit 2 No
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