Fish Oil and Aspirin With Type 2 Diabetes

NCT01181882 | Completed Phase 2 DMC

• 1 other identifier: RSRB00030668
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Disease

Keywords

Cardiovascular Disease; Aspirin Resistance; Diabetes Mellitus, Type 2; Platelet Function; Omega-3 Fatty Acids; Aspirin; Lysophospholipids; Lysophosphatidic Acid; Lysophosphatidylcholine

Outcome Measures

Primary Outcomes (1)

• Platelet function

  Platelet function effect will be measured with aspirin alone and 4 hours later, after fish oil ingestion.

  4 hours

Secondary Outcomes (1)

• Lysophospholipids

  4 hours

Study Arms (1)

Fish Oil and Aspirin

EXPERIMENTAL

Dietary Supplement: Fish Oil and Aspirin

Interventions

Fish Oil and Aspirin DIETARY_SUPPLEMENT

4 grams of fish oil each day for 28 days and 81 mg aspirin

Also known as: Omega-3 EPA/DHA Concentrate, Aspirin

Fish Oil and Aspirin

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;
• 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

Sponsors & Collaborators

• University of Rochester: lead
• Cornell University: collaborator
• Albany College of Pharmacy and Health Sciences: collaborator

Study Sites (1)

Clinical Research Center of the University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (3)

• 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.

  PMID: 25555354 DERIVED

• 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.

  PMID: 24373610 DERIVED

• 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.

  PMID: 23664596 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus, Type 2

Interventions

Fish Oils; Aspirin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Oils; Lipids; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Robert C Block, MD, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 3, 2010
• First Posted: August 13, 2010
• Study Start: August 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: November 1, 2012
• Last Updated: October 8, 2013

Record last verified: 2013-10

Locations

US (1)