Effect of Atorvastatin on Vascular Inflammation in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Effect of Atorvastatin on Vascular Inflammation in Type 2 Diabetes: Analysis With 18F-Fluorodeoxyglucose Positron Emission Tomography

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00932048
• Other study ID #: R0709211
• Status: Withdrawn
• Phase: N/A
• First received: July 1, 2009
• Last updated: September 5, 2013
• Start date: August 2011
• Est. completion date: March 2012

Study information

• Verified date: July 2009
• Source: Korea University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Atorvastatin
Atorvastatin 10mg once daily for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Tae Nyun Kim	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular inflammation analyzed by PET: Define attenuation of plaque inflammation (plaque SUV or TBR) at 12 weeks		12 weeks	No
Secondary	Change in LDL-cholesterol levels after active treatment		12 weeks	No
Secondary	Biomarkers: hs-CRP, adiponectin, MCP-1, PAI-1, TNF-a, IL-6		12 weeks	No
Secondary	Change in carotid plaque thickness by ultrasound		12 weeks	No