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

History of Changes

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:

MedlinePlus related topics: Atherosclerosis

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Measurement of intima media thickness, visit 1 [ Time Frame: Visit 1 ]
Measurement of intima media thickness, visit 2 [ Time Frame: Visit 2 ]

Secondary Outcome Measures:

hs-C-Reactive Protein, visit 1 [ Time Frame: Visit 1 ]
hs-C-Reactive Protein, visit 2 [ Time Frame: Visit 2 ]

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)

Groups/Cohorts
1

Detailed Description:

MC MD

Eligibility


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

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	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

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

Hong EG, Ohn JH, Lee SJ, Kwon HS, Kim SG, Kim DJ, Kim DS. Clinical implications of carotid artery intima media thickness assessment on cardiovascular risk stratification in hyperlipidemic Korean adults with diabetes: the ALTO study. BMC Cardiovasc Disord. 2015 Oct 6;15:114. doi: 10.1186/s12872-015-0109-y.


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

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

ClinicalTrials.gov processed this record on June 23, 2017

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