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

NCT ID: NCT00770679

Last Updated: 2017-09-13

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-07-31

Brief Summary

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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

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Correct

Conditions

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Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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High-Dose Statin

80 mg atorvastatin daily for 3 weeks

Group Type EXPERIMENTAL

lipitor

Intervention Type DRUG

80 mg everyday (QD) for 3 weeks

Interventions

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lipitor

80 mg everyday (QD) for 3 weeks

Intervention Type DRUG

Other Intervention Names

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atorvastatin

Eligibility Criteria

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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).
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harry Silber, MD

Role: PRINCIPAL_INVESTIGATOR

JHU

Locations

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Harry SIlber, MD

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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NA00002253

Identifier Type: -

Identifier Source: org_study_id

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