Effect of Atorvastatin on Vascular Inflammation in Type 2 Diabetes

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Korea University
ClinicalTrials.gov Identifier:
NCT00932048
First received: July 1, 2009
Last updated: September 5, 2013
Last verified: July 2009
  Purpose

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 Intervention
Type 2 Diabetes
Atherosclerosis
Drug: Atorvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Atorvastatin on Vascular Inflammation in Type 2 Diabetes: Analysis With 18F-Fluorodeoxyglucose Positron Emission Tomography

Resource links provided by NLM:


Further study details as provided by Korea University:

Primary Outcome Measures:
  • Vascular inflammation analyzed by PET: Define attenuation of plaque inflammation (plaque SUV or TBR) at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in LDL-cholesterol levels after active treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Biomarkers: hs-CRP, adiponectin, MCP-1, PAI-1, TNF-α, IL-6 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in carotid plaque thickness by ultrasound [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: August 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Experimental: Atorvastatin Drug: Atorvastatin
Atorvastatin 10mg once daily for 12 weeks

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.

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00932048

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

No publications provided

Responsible Party: Kyung Mook Choi, Korea University
ClinicalTrials.gov Identifier: NCT00932048     History of Changes
Other Study ID Numbers: R0709211
Study First Received: July 1, 2009
Last Updated: September 5, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Korea University:
Diabetes Mellitus
Statins
PET

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

ClinicalTrials.gov processed this record on October 29, 2014