Systematic Review and Meta-analysis of Randomized Controlled Trials of the Effect of Fish Oil Supplementation on Cardiovascular Outcomes in Diabetes
Sponsor study identifier
observational
1
1 country
1
Study Start
March 28, 2020
Actual (reported)Primary Completion
March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 28, 2020
Actual (reported)March 28, 2020
Actual (reported)March 31, 2020
Actual (reported)March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Total cardiovascular disease (CVD) incidence
Risk ratio of fatal and non-fatal CVD events
at least 1 year
Major adverse cardiovascular events (MACE)
at least 1 year
CVD mortality
at least 1 year
All-cause mortality
fish oil supplementation, usually capsules with a defined content of EPA and DHA dosage and duration of intervention differ between the included studies of our meta-analysis
placebo supplementation, usually capsules with a defined content of non-fish oil or other components content, dosage and duration of intervention differ between the included studies of our meta-analysis
daily fish oil supplement vs. placebo
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
People with type 2 diabetes mellitus
Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, M5C 2T2, Canada
John L Sievenpiper, MD,PhD,FRCPC
University of Toronto
First Submitted
March 28, 2020
First Posted
March 31, 2020
Study Start
March 28, 2020
Actual (reported)Primary Completion
March 2021
Estimated (date passed)Omega-3 Supplement and Health Markers
at least 1 year
Coronary heart disease (CHD) incidence
at least 1 year
Coronary heart disease (CHD) mortality
at least 1 year
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 4, 2020
Record last verified: 2020-11
We don't have access to individual participant data, as we are conducting a systematic review and meta-analysis.
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Source: ClinicalTrials.gov.
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