Fish Oil and Aspirin With Type 2 Diabetes (R-21)
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.
Dietary Supplement: Fish Oil and Aspirin
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||The Effects of Fish Oil and Aspirin on Cardiovascular Risk in Type 2 Diabetes|
- Platelet function [ Time Frame: 4 hours ] [ Designated as safety issue: No ]Platelet function effect will be measured with aspirin alone and 4 hours later, after fish oil ingestion.
- Lysophospholipids [ Time Frame: 4 hours ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2010|
|Study Completion Date:||November 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
|Experimental: Fish Oil and Aspirin||
Dietary Supplement: Fish Oil and Aspirin
4 grams of fish oil each day for 28 days and 81 mg aspirin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181882
|United States, New York|
|Clinical Research Center of the University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Robert C Block, MD, MPH||University of Rochester|