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Cardiovascular DiseasePhase 2R-21NCT01181882

Fish Oil and Aspirin With Type 2 Diabetes

A Phase 2 study testing Fish Oil and Aspirin in people with Cardiovascular Disease, run by University of Rochester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to understand if omega-3 fatty acids in fish oil enhance the ability of aspirin to reduce the risk of cardiovascular diseases such as heart attack and stroke in those who have diabetes mellitus. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Cardiovascular Disease
What is being tested?
Fish Oil and Aspirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Aug 2010to Nov 2012
Phase
Phase 2
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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Between the ages of 40-80
  • No significant abnormality noted from the CBC, CMP, TSH
  • Have diabetes mellitus based on the criteria from the Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. (57) These data will be collected from medical records in conjunction with the Greater Rochester Practice-Based Research Network (see recruitment plan below)
  • Symptoms of diabetes plus casual plasma glucose concentration greater than or equal to 200 mg/dl (11.1 mmol/l). Casual is defined as any time of day without regard to last time since last meal. The classic symptoms of diabetes include polyuria, polydipsia, and unexplained weight loss, or;
  • Fasting plasma glucose greater than or equal to 126 mg/dl (11.1 mmol/l). Fasting is defined as no caloric intake for at least 8 h, or;
  • 2-hour plasma glucose greater than or equal to 200 mg/dl (11.1 mmol/l) during an oral glucose tolerance test. The test should be performed as described by the World Health organization, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water. This is the protocol within the University of Rochester Clinical Labs.
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  • (In the absence of unequivocal hyperglycemia with acute metabolic decompensation, these criteria should have been confirmed by repeat testing on a different day)
  • Available for two morning visits (5 hours at bedrest) approximately 28 days apart and 2 short visits for blood draws
  • No fish oil, flax seed oil, vitamins, nutri. supplements or herbal preps. during study
  • Able to commit to no aspirin, NSAIDS for 10 days prior to each 5-hour study visit
  • Able to commit to no more then 2 meals of fish 7 days prior to each visit
  • Non-smoker
  • Not currently pregnant, and will not become pregnant during study

Who cannot join

  • History of drug or alcohol abuse, or current weekly alcohol consumption >14 units/week (1 unit=1 beer, 1 glass of wine, 1 mixed cocktail containing 1 ounce of alcohol)
  • Diagnosis of cardiovascular disease including coronary heart disease, congestive heart failure, peripheral vascular disease, stroke, atrial fibrillation, and gastric bypass surgery or malabsorption syndrome.
  • History of malignancy (unless disease free for >10 years, or non-melanoma skin carcinoma)
  • History of peptic ulcer or gastrointestinal bleeding in past 5 years
  • Diagnosed bleeding disorder
  • Use of antiplatelet or antithrombotic therapy, defined as clopidogrel, ticlopidine, cilostazol, dipyridamol, trapidil, warfarin, and argatroban

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Clinical Research Center of the University of Rochester Medical Center

    Rochester, New York, 14642

Other trials in United States

About this study

Official title: The Effects of Fish Oil and Aspirin on Cardiovascular Risk in Type 2 Diabetes

The purpose of this study is to understand if omega-3 fatty acids in fish oil enhance the ability of aspirin to reduce the risk of cardiovascular diseases such as heart attack and stroke in those who have diabetes mellitus.

Read the detailed description

A recent increase in the incidence and prevalence of obesity-related diabetes mellitus and the metabolic syndrome as a result of insulin resistance threatens to reverse the health gains achieved in the US during the last half of the 20th century. Novel inexpensive and safe pharmacologic approaches are required to prevent a variety of resulting cardiovascular disease sequelae. Aspirin is a proven agent in the treatment and prevention of cardiovascular disease but is greatly underused. Even when it is used, aspirin is ineffective in a large proportion of the population: a problem termed "aspirin resistance." Approximately thirty percent of the adult US population is aspirin resistant and this proportion is higher in those with diabetes and the metabolic events and affected patients do not benefit from other antiplatelet drugs. The omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are naturally occurring and can be safely used at low cost in individuals who are in high and lower cardiovascular risk groups. Supplementation with EPA and and DHA (EPA + DHA) modifies the fatty acid balance which is distributed in patients with insulin resistance and atherosclerosis, thereby potentially improving endothelial function, lowering blood pressure, and reducing the risk of fatal and non-fatal acute coronary syndromes. Emerging evidence indicates that the combination of aspirin together with EPA+DHA supplementation beneficially regulates fatty acid metabolism and attenuates atherosclerosis. However, the effects of aspirin together with EPA + DHA on aspirin resistance or in subjects with diabetes mellitus and insulin resistance are unknown. Circulating EPA and DHA are contained largely in lysophospholipids, which contain a three carbon backbone and variable fatty acyl side chains. In preliminary data, we show that both aspirin ingestion and EPA+DHA supplementation after lysophospholipids including lysophosphatidylcholine (LPC) and lysophosphatidic acid (LPA) are now known to bind specific G-protein coupled receptors, which are being explored as novel therapeutic targets in cardiovascular and other diseases. Relationships between LPC and LPA metabolism, aspirin ingestion, and human atherosclerosis have not been investigated (to our knowledge). In the proposed study, we will investigate the effects of combining aspirin with EPA+DHA supplementation on platelet function and lysophospholipid metabolism in a clinical trial of individuals with type 2 diabetes mellitus. This trial will build on existing infrastructure in clinical and translational research, as well as our preliminary data using novel in-house assays.

Being tested
Fish Oil and Aspirin
Keywords
Cardiovascular Disease, Aspirin Resistance, Diabetes Mellitus, Type 2, Platelet Function, Omega-3 Fatty Acids, Aspirin, Lysophospholipids, Lysophosphatidic Acid, Lysophosphatidylcholine
Medical subject headings
Cardiovascular Diseases, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fish Oil and AspirinDietary supplement

    Also called Omega-3 EPA/DHA Concentrate, Aspirin

    4 grams of fish oil each day for 28 days and 81 mg aspirin

Study groups in NCT01181882
Study groupRoleWhat they receive
Fish Oil and AspirinExperimentalNot described
Receives: Dietary Supplement: Fish Oil and Aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Platelet function

    Platelet function effect will be measured with aspirin alone and 4 hours later, after fish oil ingestion.

    Measured: 4 hours

Secondary outcomes (1)

  1. Lysophospholipids

    Plasma measurement of lysophospholipids will be measured with aspirin alone and 4 hours later, after fish oil ingestion. These analyses will be considered exploratory due to the fact that no previous data exist regarding the relationships investigated and multiple testing is inherent to these analyses as 11 species of each LPA and LPC will be measured.

    Measured: 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionMar 2012
  4. Study completionNov 2012

Resources

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 2
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01181882
Sponsor's protocol ID
RSRB00030668
Acronym
R-21
Status last verified
Oct 2013
First submitted
3 Aug 2010
Last updated
8 Oct 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Block RC, Abdolahi A, Tu X, Georas SN, Brenna JT, Phipps RP, Lawrence P, Mousa SA. The effects of aspirin on platelet function and lysophosphatidic acids depend on plasma concentrations of EPA and DHA. Prostaglandins Leukot Essent Fatty Acids. 2015 May;96:17-24. doi: 10.1016/j.plefa.2014.12.005. Epub 2014 Dec 22.

    PubMed 25555354

  • Abdolahi A, Georas SN, Brenna JT, Cai X, Thevenet-Morrison K, Phipps RP, Lawrence P, Mousa SA, Block RC. The effects of aspirin and fish oil consumption on lysophosphatidylcholines and lysophosphatidic acids and their correlates with platelet aggregation in adults with diabetes mellitus. Prostaglandins Leukot Essent Fatty Acids. 2014 Feb-Mar;90(2-3):61-8. doi: 10.1016/j.plefa.2013.12.004. Epub 2013 Dec 18.

    PubMed 24373610

  • Block RC, Abdolahi A, Smith B, Meednu N, Thevenet-Morrison K, Cai X, Cui H, Mousa S, Brenna JT, Georas S. Effects of low-dose aspirin and fish oil on platelet function and NF-kappaB in adults with diabetes mellitus. Prostaglandins Leukot Essent Fatty Acids. 2013 Jul;89(1):9-18. doi: 10.1016/j.plefa.2013.03.005. Epub 2013 May 7.

    PubMed 23664596

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fish Oil and Aspirin in people with Cardiovascular Disease, run by University of Rochester 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 13 inclusion and 6 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: finished, as of the sponsor's last update on 8 Oct 2013. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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.

What does the primary outcome measure?

Platelet function (time frame: 4 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01181882, which also lists 3 linked publications.

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 8 Oct 2013.

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