AtherosclerosisNCT00037401
Postprandial Lipemia and Endothelial Function in ACCORD- Ancillary to ACCORD
An observational study of Atherosclerosis and Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To compare the effects of statin therapy alone with statin plus fibrate therapy on several emerging risk factors for atherosclerotic cardiovascular disease in a representative subgroup of the ACCORD cohort that is being followed for cardiovascular endpoints. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Atherosclerosis, Cardiovascular Diseases, Hypercholesterolemia
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 2001to Aug 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
No eligibility criteria
About this study
To compare the effects of statin therapy alone with statin plus fibrate therapy on several emerging risk factors for atherosclerotic cardiovascular disease in a representative subgroup of the ACCORD cohort that is being followed for cardiovascular endpoints.
Read the detailed description
BACKGROUND:
The National Heart, Lung, and Blood Institute-supported ACCORD trial uses two connected 2x2 designs to test the efficacy of (a) optimal glucose control (HbA1c = 6.0%) versus standard control (HbA1c + 7.5%) in 10,000 patients with type 2 diabetes mellitus, (b) more intense systolic blood pressure control (120 mm Hg) versus less intense control (140 mm Hg) in 4,200 of those patients, and (c) combined low density lipoprotein cholesterol lowering, triglyceride lowering, and high density lipoprotein cholesterol raising versus only low density lipoprotein cholesterol lowering in 5,800 of those patients. The primary outcome for the overall ACCORD trial is a combination of non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death. The comparison of lipid-altering therapies is carried out in the Lipid Arm of ACCORD, in which the 5,800 subjects are treated with simvastatin and, in addition, are randomly assigned to receive either fenofibrate or placebo. The main ACCORD trial measures only fasting blood samples for lipids, lipoprotein fractions, and apolipoproteins. The ancillary study compares the effects of simvastatin plus fenofibrate with the effects of simvastatin alone on postprandial lipemia in 250 ACCORD patients at 4 sites in the Northeast Network.
The study is in response to an initiative on Ancillary Studies in Heart, Lung, and Blood Disease Trials released in June, 2000.
DESIGN NARRATIVE:
The ancillary study compares the effects of simvastatin plus fenofibrate with the effects of simvastatin alone on postprandial lipemia in 250 ACCORD patients at 4 sites in the Northeast Network. In addition, the study compare the effects of the two treatment strategies on baseline and postprandial endothelial function, and on markers of coagulation, endothelial function, and oxidative stress. The ancillary study provides a unique opportunity to determine possible mechanisms whereby simvastatin plus fenofibrate therapy may be associated with reduced cardiovascular events in the overall ACCORD trial. The study is divided into three specific aims. Specific Aim A: To carry out high fat load studies of postprandial lipemia in patients who are participating in the Lipid Arm of the ACCORD trial and compare postprandial excursions of triglycerides, triglyceride-rich lipoproteins, retinyl palmitate, and remnant lipoprotein cholesterol in patients receiving fenofibrate plus simvastatin with those postprandial excursions in patients receiving only simvastatin. Specific Aim B: To determine brachial artery dilatation in response to increased blood flow post- forearm ischemia just prior to, and five hours after, ingestion of a high fat load in the two patient groups.and Specific Aim C: To determine baseline levels of PAI-1, fibrinogen and factor VII, and postprandial excursions of factor VII, sVCAM-1, sICAM-1, and sE-selectin in the two patient groups.
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases, Hypercholesterolemia, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2002 (estimated)
- Study startSep 2001
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
- Observational
- Time perspective
- Retrospective
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Henry Ginsberg, Columbia University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00037401
- Sponsor's protocol ID
- 1168
- Other IDs
- R01HL069190
- Status last verified
- Jan 2008
- First submitted
- 16 May 2002
- Last updated
- 18 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Lipemia and Endothelial Function in ACCORD- Ancillary to ACCORD
- ClinicalTrials.gov ID
- NCT00037401
- Acronym / sponsor ID
- 1168
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 2001
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 17 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the effects of statin therapy alone with statin plus fibrate therapy on several emerging risk factors for atherosclerotic cardiovascular disease in a representative subgroup of the ACCORD cohort that is being followed for cardiovascular endpoints.
Detailed description
BACKGROUND:
The National Heart, Lung, and Blood Institute-supported ACCORD trial uses two connected 2x2 designs to test the efficacy of (a) optimal glucose control (HbA1c = 6.0%) versus standard control (HbA1c + 7.5%) in 10,000 patients with type 2 diabetes mellitus, (b) more intense systolic blood pressure control (120 mm Hg) versus less intense control (140 mm Hg) in 4,200 of those patients, and (c) combined low density lipoprotein cholesterol lowering, triglyceride lowering, and high density lipoprotein cholesterol raising versus only low density lipoprotein cholesterol lowering in 5,800 of those patients. The primary outcome for the overall ACCORD trial is a combination of non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death. The comparison of lipid-altering therapies is carried out in the Lipid Arm of ACCORD, in which the 5,800 subjects are treated with simvastatin and, in addition, are randomly assigned to receive either fenofibrate or placebo. The main ACCORD trial measures only fasting blood samples for lipids, lipoprotein fractions, and apolipoproteins. The ancillary study compares the effects of simvastatin plus fenofibrate with the effects of simvastatin alone on postprandial lipemia in 250 ACCORD patients at 4 sites in the Northeast Network.
The study is in response to an initiative on Ancillary Studies in Heart, Lung, and Blood Disease Trials released in June, 2000.
DESIGN NARRATIVE:
The ancillary study compares the effects of simvastatin plus fenofibrate with the effects of simvastatin alone on postprandial lipemia in 250 ACCORD patients at 4 sites in the Northeast Network. In addition, the study compare the effects of the two treatment strategies on baseline and postprandial endothelial function, and on markers of coagulation, endothelial function, and oxidative stress. The ancillary study provides a unique opportunity to determine possible mechanisms whereby simvastatin plus fenofibrate therapy may be associated with reduced cardiovascular events in the overall ACCORD trial. The study is divided into three specific aims. Specific Aim A: To carry out high fat load studies of postprandial lipemia in patients who are participating in the Lipid Arm of the ACCORD trial and compare postprandial excursions of triglycerides, triglyceride-rich lipoproteins, retinyl palmitate, and remnant lipoprotein cholesterol in patients receiving fenofibrate plus simvastatin with those postprandial excursions in patients receiving only simvastatin. Specific Aim B: To determine brachial artery dilatation in response to increased blood flow post- forearm ischemia just prior to, and five hours after, ingestion of a high fat load in the two patient groups.and Specific Aim C: To determine baseline levels of PAI-1, fibrinogen and factor VII, and postprandial excursions of factor VII, sVCAM-1, sICAM-1, and sE-selectin in the two patient groups.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
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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.
Henry Ginsberg
Columbia University Health Sciences
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 18 Feb 2016.