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TerminatedNCT00770679Updated Sep 13, 2017Results posted

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

An interventional study of lipitor in Diabetes, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-09-13.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Diagnostic

Why this study was terminated
Delayed recruitment, funding exhausted

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jun 2008, registered Oct 2008).
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
40 Years to 90 Years
Sex
All
01

Study 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.

Read the detailed description

Correct

02

Conditions studied

  • Diabetes
03

In context

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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).
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    High-Dose Statin

    80 mg atorvastatin daily for 3 weeks

    Drug: lipitor

Interventions

  • Druglipitor

    80 mg everyday (QD) for 3 weeks

    Also known as: atorvastatin

06

What researchers measure

Primary outcomes

  1. Mean Change in Low Density Lipoprotein (LDL)

    Serum LDL, mg/dL (baseline LDL-follow-up LDL)

    Time frame: Change from baseline to follow-up, up to 5 weeks

  2. Change in Endothelial Function as Measured on MRI in the Arms

    Time frame: chance from baseline to end of study, up to 5 weeks

  3. Change in Endothelial Function as Measured on MRI in the Legs

    Time frame: chance from baseline to end of study, up to 5 weeks

07

Results

Posted Sep 13, 2017

Participant flow

Participant flow — Overall Study
MilestoneHigh-Dose Statin
Started16
Completed10
Not completed6
Withdrew: Lost to follow-up3
Withdrew: Follow-up ldl measurement not collected3

Outcome measures

PrimaryMean Change in Low Density Lipoprotein (LDL)

Serum LDL, mg/dL (baseline LDL-follow-up LDL)

Time frame:
Change from baseline to follow-up, up to 5 weeks
Reported as:
Mean · mg/dL
Mean Change in Low Density Lipoprotein (LDL)
mg/dLHigh-Dose Statin
Mean Change in Low Density Lipoprotein (LDL)75.54 ± 12.98
PrimaryChange in Endothelial Function as Measured on MRI in the Arms
Time frame:
chance from baseline to end of study, up to 5 weeks

No measurements were reported for this outcome.

PrimaryChange in Endothelial Function as Measured on MRI in the Legs
Time frame:
chance from baseline to end of study, up to 5 weeks

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
High-Dose Statin0/16 (0%)0/16 (0%)0/16 (0%)

Baseline characteristics

Age, Customized
Age, Customized(Participants)High-Dose Statin
>=40, <=90, years16
Sex: Female, Male
Sex: Female, Male(Participants)High-Dose Statin
Female6
Male10
Region of Enrollment
Region of Enrollment(Participants)High-Dose Statin
United States16
08

Study locations

1 site
  • Harry SIlber, MD
    Baltimore, Maryland 21224, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00770679
Lead sponsor
Johns Hopkins University
Collaborators
Pfizer
Responsible party
Sponsor
First posted
Oct 10, 2008
Start date
Jun 2008
Primary completion
Jul 2012
Completion
Jul 2012
Results posted
Sep 13, 2017
Last update
Sep 13, 2017

Study contacts

Harry Silber, MD
principal investigator · JHU

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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