Fish Oil and Aspirin With Type 2 Diabetes
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): Fish Oil and Aspirin
Intervention type(s): Dietary Supplement
Intervention description(s): 4 grams of fish oil each day for 28 days and 81 mg aspirin
Other intervention name(s): Omega-3 EPA/DHA Concentrate; Aspirin
Intervention MeSH terms: Aspirin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Cardiovascular Disease; Aspirin Resistance; Diabetes Mellitus, Type 2; Platelet Function; Omega-3 Fatty Acids; Aspirin; Lysophospholipids; Lysophosphatidic Acid; Lysophosphatidylcholine