Effect of Atorvastatin on Vascular Inflammation in Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00932048
Recruitment Status : Withdrawn
First Posted : July 2, 2009
Last Update Posted : September 6, 2013
Information provided by:
Korea University

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Atherosclerosis Drug: Atorvastatin Not Applicable

Detailed Description:
The early detection of vulnerable plaques is clinically important for risk stratification and also to provide early treatment. Inflammation is important in the both pathogenesis and outcome of atherosclerosis. Plaques containing numerous inflammatory cells, particular macrophages, have a high risk of rupture. Diabetes is a major risk factor for the development of atherosclerosis. Lipid-lowering therapy with statins significantly decreases cardiovascular morbidity and mortality in primary and secondary prevention. Statin exert their benefits through the inhibition of de novo cholesterol synthesis, resulting in significant reductions in plasma low-density lipoprotein cholesterol (LDL-C) levels. It remains controversial whether LDL-C lowering is the only mechanism for the observed beneficial effects. Many LDL-C-independent pleiotropic effects have been postulated. Moreover, Lipid lowering therapy may affect atherosclerosis also through the inhibition of inflammatory marker. These evidences highlight the possibility of statins could be have great impact on plaque inflammation. 18FDG is a glucose analogue that is taken up by cells in proportion to their metabolic activity. Several papers have reported the potential roles of metabolic imaging in the assessment of inflammatory vascular diseases, especially in large vessels. If so, FDG-PET can monitor the direct effect of statins on vascular inflammation. Additionally, monitoring the vascular inflammation by FDG-PET may be useful for determining the risk stratification of atherosclerotic patients. The investigators hypothesize that statins-induced attenuation of vascular inflammation could be monitored clinically by use of FDG-PET approach, and providing information of early efficacy statins therapy caused by stabilization of vulnerable plaque without affecting the lumen size.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Atorvastatin on Vascular Inflammation in Type 2 Diabetes: Analysis With 18F-Fluorodeoxyglucose Positron Emission Tomography
Study Start Date : August 2011
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Control
Experimental: Atorvastatin Drug: Atorvastatin
Atorvastatin 10mg once daily for 12 weeks

Primary Outcome Measures :
  1. Vascular inflammation analyzed by PET: Define attenuation of plaque inflammation (plaque SUV or TBR) at 12 weeks [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change in LDL-cholesterol levels after active treatment [ Time Frame: 12 weeks ]
  2. Biomarkers: hs-CRP, adiponectin, MCP-1, PAI-1, TNF-α, IL-6 [ Time Frame: 12 weeks ]
  3. Change in carotid plaque thickness by ultrasound [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 2 diabetic patients who are aged 35 to 80 year-old

Exclusion Criteria:

  • 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)

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 identifier (NCT number): NCT00932048

Korea, Republic of
Tae Nyun Kim
Seoul, Korea, Republic of, 152-050
Sponsors and Collaborators
Korea University
Principal Investigator: Kyung Mook Choi, MD. PhD Korea University

Responsible Party: Kyung Mook Choi, Korea University Identifier: NCT00932048     History of Changes
Other Study ID Numbers: R0709211
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: September 6, 2013
Last Verified: July 2009

Keywords provided by Korea University:
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors