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

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: December 17, 2010
Last updated: March 12, 2012
Last verified: March 2012

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.

Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prevalence of Subclinical Atherosclerosis and Its Associated Factors in Hyperlipidemic Korean Adults With Diabetes

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Measurement of intima media thickness, visit 1 [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]
  • Measurement of intima media thickness, visit 2 [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • hs-C-Reactive Protein, visit 1 [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]
  • hs-C-Reactive Protein, visit 2 [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Whole blood and serum, urine

Enrollment: 181
Study Start Date: January 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)

Detailed Description:



Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

360 patients who has diabetic mellitus with dyslipidemia


Inclusion Criteria:

  • patients with Diabetic Mellitus
  • patients with dyslipidemia

Exclusion Criteria:

  • patients who have established cardiovascular disease
  • patient using NSAID
  Contacts and Locations
Please refer to this study by its identifier: NCT01264263

Korea, Republic of
Research Site
Anyang, Korea, Republic of
Research Site
Koyang, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Sponsors and Collaborators
Study Chair: Dongsun Kim Hanyang University
Principal Investigator: Eunkyung Hong 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

No publications provided

Responsible Party: AstraZeneca Identifier: NCT01264263     History of Changes
Other Study ID Numbers: NIS-CKR-DUM-2010/1
Study First Received: December 17, 2010
Last Updated: March 12, 2012
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Diabetes Mellitus
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders processed this record on April 17, 2014