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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01264263
First received: December 17, 2010
Last updated: March 12, 2012
Last verified: March 2012
  Purpose

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
Diabetes Mellitus
Dyslipidemia

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:

MC MD

  Eligibility

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

Criteria

Inclusion Criteria:

  • patients with Diabetic Mellitus
  • patients with dyslipidemia

Exclusion Criteria:

  • patients who have established cardiovascular disease
  • patient using NSAID
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 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
ClinicalTrials.gov 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:
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:
Atherosclerosis
Arteriosclerosis
Diabetes Mellitus
Dyslipidemias
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on August 26, 2014