- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01181882
Fish Oil and Aspirin With Type 2 Diabetes (R-21)
The Effects of Fish Oil and Aspirin on Cardiovascular Risk in Type 2 Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
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Rochester, New York, United States, 14642
- Clinical Research Center of the University of Rochester Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
(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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fish Oil and Aspirin
|
4 grams of fish oil each day for 28 days and 81 mg aspirin
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Platelet function
Time Frame: 4 hours
|
Platelet function effect will be measured with aspirin alone and 4 hours later, after fish oil ingestion.
|
4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lysophospholipids
Time Frame: 4 hours
|
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.
|
4 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert C Block, MD, MPH, University of Rochester
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- RSRB00030668
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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