Effect of Atorvastatin on Vascular Inflammation in Type 2 Diabetes
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Type 2 diabetes mellitus significantly increases the risk for the development of atherosclerosis. Recently, atherosclerosis imaging with 18F-FDG PET (18F-Fluorodeoxyglucose Positron Emission Tomography) is useful for tracking inflammation within plaque and monitoring the response to drug therapy The purpose of this study is to determine whether FDG-PET is capable of detecting atherosclerotic vascular inflammation and monitoring the early effects of statins in type 2 diabetic patients. The usefulness of FDG-PET in risk stratification is also investigated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2011
Shorter than P25 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2009
CompletedFirst Posted
Study publicly available on registry
July 2, 2009
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedSeptember 6, 2013
July 1, 2009
5 months
July 1, 2009
September 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vascular inflammation analyzed by PET: Define attenuation of plaque inflammation (plaque SUV or TBR) at 12 weeks
12 weeks
Secondary Outcomes (3)
Change in LDL-cholesterol levels after active treatment
12 weeks
Biomarkers: hs-CRP, adiponectin, MCP-1, PAI-1, TNF-α, IL-6
12 weeks
Change in carotid plaque thickness by ultrasound
12 weeks
Study Arms (2)
Control
NO INTERVENTIONAtorvastatin
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetic patients who are aged 35 to 80 year-old
You may not qualify if:
- Insulin use
- Patients who receive any dyslipidaemia under medications (including statins) in recent one year
- Women of child-bearing potential are excluded (i.e. menopausal women or post-hysterectomy women are included in this study) due to radiation exposure in this study
- Active inflammatory diseases
- Vasculitis, symptomatic coronary artery disease, symptomatic cerebrovascular diseases
- Significant concomitant disease such as active infection, malignancy, hepatic or renal dysfunction at the time of enrollment (i.e. T-Bil \> 3 mg/dl，ALT \> 2.5 times the upper limit of normal range and Creatinine \> 2 mg/dl in our hospital)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Korea Universitylead
Study Sites (1)
Tae Nyun Kim
Seoul, 152-050, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyung Mook Choi, MD. PhD
Korea University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 1, 2009
First Posted
July 2, 2009
Study Start
August 1, 2011
Primary Completion
January 1, 2012
Study Completion
March 1, 2012
Last Updated
September 6, 2013
Record last verified: 2009-07