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Meta-analysis of Fish Oil Supplementation and Cardiovascular Outcomes in Diabetes

NCT04327713 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2020-11-04

No results posted yet for this study

Summary

Fish oil contains a large amount of long-chain omega-3 polyunsaturated fatty acids, which are considered an important component of a healthy diet. As many patients do not eat fish, supplementation with fish oil is a common strategy to provide sufficient amounts of these particular fatty acids in daily life. Fish oil supplementation has been investigated for decades for its cardio-protective effects and its ability to lower serum triglycerides. People with diabetes mellitus have an increased risk for cardiovascular events and show alterations in lipids with high triglycerides. Whether there is a benefit of fish oil supplementation in this high risk group remains unclear with major international diabetes associations recommending against the use of fish oil supplements. The European Association for the Study of Diabetes (EASD) has not made any recommendations about the use of fish oils in people with diabetes since 2004. To inform the update of the EASD clinical practice guidelines for nutrition therapy, the Diabetes and Nutrition Study Group (DNSG) of the EASD has commissioned the proposed systematic review and meta-analysis of randomized controlled trials of the effect of fish oil supplementation on cardiovascular outcomes in people with diabetes and use the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the certainty of the evidence.

Conditions

Interventions

DIETARY_SUPPLEMENT

fish oil supplement

daily fish oil supplement vs. placebo

Sponsors & Collaborators

  • Diabetes and Nutrition Study Group (DNSG) of the European Association for the Study of Diabetes (EASD)

    collaborator UNKNOWN

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Diabetes Canada

    collaborator OTHER

  • University of Toronto

    lead OTHER

Principal Investigators

  • John L Sievenpiper, MD,PhD,FRCPC · University of Toronto

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-28
Primary Completion
2021-03-31
Completion
2021-04-30

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04327713 on ClinicalTrials.gov