Fish Oil and Aspirin With Type 2 Diabetes

Completed · Phase 2

Conditions studied: Cardiovascular Disease

In brief

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.

Key facts

Study ID

NCT01181882

Run by

University of Rochester

People needed

30

Starts

2010-08-01

Expected to finish

2012-11-01

Last updated by the study team

2013-10-08

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Research Center of the University of Rochester Medical Center — Rochester, New York, United States

Full record on ClinicalTrials.gov

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