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

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ClinicalTrials.gov Identifier: NCT01264263
Recruitment Status : Completed
First Posted : December 21, 2010
Last Update Posted : March 13, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief 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.

Condition or disease
Diabetes Mellitus Dyslipidemia

Detailed Description:
MC MD

Study Design
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Study Type : Observational
Actual Enrollment : 181 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prevalence of Subclinical Atherosclerosis and Its Associated Factors in Hyperlipidemic Korean Adults With Diabetes
Study Start Date : January 2011
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
1


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Measurement of intima media thickness, visit 1 [ Time Frame: Visit 1 ]
  2. Measurement of intima media thickness, visit 2 [ Time Frame: Visit 2 ]

Secondary Outcome Measures :
  1. hs-C-Reactive Protein, visit 1 [ Time Frame: Visit 1 ]
  2. hs-C-Reactive Protein, visit 2 [ Time Frame: Visit 2 ]

Biospecimen Retention:   Samples Without DNA
Whole blood and serum, urine

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
360 patients who has diabetic mellitus with dyslipidemia
Criteria

Inclusion Criteria:

  • patients with Diabetic Mellitus
  • patients with dyslipidemia

Exclusion Criteria:

  • patients who have established cardiovascular disease
  • patient using NSAID
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01264263


Locations
Korea, Republic of
Research Site
Anyang, Korea, Republic of
Research Site
Koyang, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Dongsun Kim Hanyang University
Principal Investigator: Eunkyung Hong Hallym University Kangnam Sacred Heart Hospital
Principal Investigator: Hyunsang Kwon Yeoido Saint Mary's Hospital
Principal Investigator: Dongjoon Kim Ilsan-Paik Hospital
Principal Investigator: Sungjin Lee Hallym University Hospital
Principal Investigator: Singon Kim Korea University Anam Hospital
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01264263     History of Changes
Other Study ID Numbers: NIS-CKR-DUM-2010/1
First Posted: December 21, 2010    Key Record Dates
Last Update Posted: March 13, 2012
Last Verified: March 2012

Keywords provided by AstraZeneca:
cIMT
hs CRP (C-reactive protein)
DM (Diabetic Mellitus)
 Korea
Corelation between cIMT (carotid intima media thickness)
Cardio Vascular risk in Diabetic Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Atherosclerosis
Dyslipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders