Fish Oil and Aspirin With Type 2 Diabetes

Launched by UNIVERSITY OF ROCHESTER · Aug 11, 2010

Keywords

ClinConnect Summary

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 "aspi...

Gender

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Eligibility criteria

• 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)
• • 1. 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;
• • 2. 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;
• • 3. 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