Effects of Statins on Lower Extremity Arterial Function Assessed by Magnetic Resonance Imaging

Not Applicable

Terminated

• Conditions: Diabetes
• Interventions: Drug: lipitor

• Registration Number: NCT00770679
• Lead Sponsor: Johns Hopkins University

Brief Summary

Cholesterol-lowering drugs called statins improve the functioning of the endothelium, and help prevent heart disease. The investigators are testing whether statins improve endothelial function more in the arteries that have worse endothelium to begin with. One of the functions of the endothelium is to help control how blood vessels dilate (expand) or contract (narrow) in different situations. This affects how blood flows through those vessels. Magnetic resonance imaging (MRI) can be used to evaluate endothelial function in the arms and legs noninvasively.

Detailed Description

Correct

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-10-09
• Study First Submitted QC: 2008-10-09
• Study First Posted: 2008-10-10
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Results First Submitted: 2017-07-17
• Status Verified: 2017-08
• Results First Submitted QC: 2017-08-14
• Last Update Submitted: 2017-08-14
• Results First Posted: 2017-09-13
• Last Update Posted: 2017-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Age 40-90
• Male or female
• Type 2 diabetes

Exclusion Criteria

• Known pregnancy or nursing.
• Females of child bearing potential must have been surgically sterilized or be post menopausal.
• Smoking
• Known vascular disease
• Inability to complete MRI scan
• Symptoms of claudication
• Use of a nitrate medicine
• Use of any cholesterol-lowering agent
• LDL < 70
• Acute illness
• Liver disease
• Contraindication to getting an MRI scan (i.e. electronic implant, shrapnel, cerebral aneurysm clip, welding history).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High-Dose Statin	lipitor	80 mg atorvastatin daily for 3 weeks

Primary Outcome Measures

Name	Time	Method
Mean Change in Low Density Lipoprotein (LDL)	Change from baseline to follow-up, up to 5 weeks	Serum LDL, mg/dL (baseline LDL-follow-up LDL)
Change in Endothelial Function as Measured on MRI in the Arms	chance from baseline to end of study, up to 5 weeks
Change in Endothelial Function as Measured on MRI in the Legs	chance from baseline to end of study, up to 5 weeks

Trial Locations

Locations (1)

Harry SIlber, MD; 🇺🇸 Baltimore, Maryland, United States