DiabetesNCT00770679
Effects of Statins on Lower Extremity Arterial Function Assessed by Magnetic Resonance Imaging
A study testing lipitor in people with Diabetes, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Diabetes
- What is being tested?
- lipitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jul 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-90
- Male or female
- Type 2 diabetes
Who cannot join
- 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
Show all 12Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Diabetes
- Being tested
- lipitor
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lipitorDrug
Also called atorvastatin
80 mg everyday (QD) for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| High-Dose Statin | Experimental | 80 mg atorvastatin daily for 3 weeks Receives: Drug: lipitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Low Density Lipoprotein (LDL)
Serum LDL, mg/dL (baseline LDL-follow-up LDL)
Measured: Change from baseline to follow-up, up to 5 weeks
Change in Endothelial Function as Measured on MRI in the Arms
Measured: chance from baseline to end of study, up to 5 weeks
Change in Endothelial Function as Measured on MRI in the Legs
Measured: chance from baseline to end of study, up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: Delayed recruitment, funding exhausted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Harry Silber, MD, Principal investigator, JHU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00770679
- Sponsor's protocol ID
- NA00002253
- Status last verified
- Aug 2017
- First submitted
- 9 Oct 2008
- Last updated
- 13 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Statins on Lower Extremity Arterial Function Assessed by Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT00770679
- Acronym / sponsor ID
- NA00002253
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Delayed recruitment, funding exhausted
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jun 2008 (actual)
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 10 Oct 2008 (estimated)
- Results
- Posted 13 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-Dose Statin | Experimental | Drug: lipitor80 mg atorvastatin daily for 3 weeks |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 40-90
- Male or female
- Type 2 diabetes
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lipitorAlso: atorvastatin80 mg everyday (QD) for 3 weeks | Drug | High-Dose Statin |
Primary outcome
Mean Change in Low Density Lipoprotein (LDL)
Time frame: 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
Time frame: chance from baseline to end of study, up to 5 weeks
Change in Endothelial Function as Measured on MRI in the Legs
Time frame: chance from baseline to end of study, up to 5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry Silber, MD principal investigator
JHU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lipitor in people with Diabetes, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Low Density Lipoprotein (LDL) (time frame: Change from baseline to follow-up, up to 5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2017.