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

NCT04327713 | Unknown

• 1 other identifier: DNSG-Fish oil
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Type2 Diabetes; Heart Failure; Myocardial Infarction; Stroke; Arrhythmia; Cardiovascular Diseases

Keywords

fish oil supplementation; Cardiovascular disease; stroke; myocardial infarction; diabetes; coronary heart disease; systematic review; meta-analysis

Outcome Measures

Primary Outcomes (1)

• Total cardiovascular disease (CVD) incidence

  Risk ratio of fatal and non-fatal CVD events

  at least 1 year

Secondary Outcomes (8)

• Major adverse cardiovascular events (MACE)

  at least 1 year

• CVD mortality

  at least 1 year

• All-cause mortality

  at least 1 year

• Coronary heart disease (CHD) incidence

  at least 1 year

• Coronary heart disease (CHD) mortality

  at least 1 year

Study Arms (2)

fish oil supplementation

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

Dietary Supplement: fish oil supplement

placebo supplementation

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

Dietary Supplement: fish oil supplement

Interventions

fish oil supplement DIETARY_SUPPLEMENT

daily fish oil supplement vs. placebo

fish oil supplementation; placebo supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People with type 2 diabetes mellitus

You may qualify if:

• Randomized controlled trials
• Participants with diabetes
• Follow-up duration ≥ 52 weeks
• Intervention involves fish oil supplementation using supplements, supplemented foods, or dietary advice
• Control group
• Ascertainment of at least one cardiovascular outcome

You may not qualify if:

• Non-randomized studies
• Participants without diabetes
• Follow-up duration \<52 weeks
• Multi-modal interventions
• Interventions of fish oils in the form of a prescription pharmaceutical drug (e.g. icosapent ethyl)
• Lack of a suitable control group (e.g. fish oil containing comparator)
• No viable cardiovascular outcome data.

Sponsors & Collaborators

• University of Toronto: lead
• Diabetes and Nutrition Study Group (DNSG) of the European Association for the Study of Diabetes (EASD): collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Diabetes Canada: collaborator

Study Sites (1)

Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

MeSH Terms

Conditions

Heart Failure; Myocardial Infarction; Stroke; Arrhythmias, Cardiac; Cardiovascular Diseases; Diabetes Mellitus; Coronary Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• John L Sievenpiper, MD,PhD,FRCPC

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 28, 2020
• First Posted: March 31, 2020
• Study Start: March 28, 2020
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)