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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00770679
• Other study ID #: NA00002253
• Status: Recruiting
• Phase: N/A
• First received: October 9, 2008
• Last updated: August 3, 2009
• Start date: July 2007
• Est. completion date: June 2010

Study information

• Verified date: August 2009
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Cholesterol-lowering drugs called statins improve the functioning of the endothelium, and help prevent heart disease. We 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. You are being asked to participate in a study using MRI to test whether a 3-week course of statins improves the endothelium of legs more than it improves the endothelium of arms.

Adults with type 2 diabetes may join.

Description:

Correct

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: June 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• lipitor
80 mg everyday (QD) for 3 weeks

Locations

Country	Name	City	State
United States	Harry SIlber, MD	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Femoral hyperemic shear rate		3 weeks	No