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Go Fish: Omega-3 Fatty Acid Supplementation in Diabetes-Related Kidney Disease

NCT ID: NCT01092390

Last Updated: 2012-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-05-31

Brief Summary

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In this application the investigators describe plans for a randomized controlled cross-over trial to determine the effects of omega-3 fatty acid supplementation on urine protein excretion in 30 adults with diabetes (NIDDM) and kidney disease defined by the presence of proteinuria.

Detailed Description

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Diabetes is the most common cause of end-stage kidney disease in the United States. Half of patients with diabetes develop kidney disease. The benefits of omega-3 fatty acids have been shown in animal models of kidney injury. Mechanistic studies of omega-3 fatty acid supplements support biological plausibility: omega-3 supplements have been shown to improve vascular reactivity, lower oxidative stress, reduce inflammation, and have beneficial effects on the metabolism of eicosanoids favoring synthesis of vasodilatory prostaglandins and thromboxanes. However, in spite of overwhelming evidence for a potential benefit of dietary omega-3 fatty acids at preventing or slowing progression of kidney disease for adults with NIDDM, clinical trials providing evidence to support recommendations of supplementation are lacking.

The current recommendation for omega-3 intake for adults, one gram/day of DHA+EPA, is based on evidence for cardiovascular disease risk (CVD) reduction. Whether omega-3 fatty acid prevents or slows progression of diabetic kidney disease, whether the current recommended dose is adequate to modify disease, or whether a higher dose should be recommended, needs to be determined.

In this setting, we propose to conduct a randomized placebo-controlled cross-over clinical trial to determine the effects of a daily dose of omega-3 fatty acid supplementation (4.0 g/day) compared with placebo on urine protein excretion and biomarkers of kidney injury and function in adults with diabetes and proteinuria.

Conditions

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Diabetes

Keywords

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randomized trial omega three fatty acids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Lovaza

4 grams per day

Group Type EXPERIMENTAL

Lovaza (fish oil)

Intervention Type DIETARY_SUPPLEMENT

4 grams per day

Interventions

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Lovaza (fish oil)

4 grams per day

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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fish oil (generic) omega three fattay acids (generic)

Eligibility Criteria

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Inclusion Criteria

* Participants have a diagnosis of diabetes (either oral medication or diet controlled)
* Have an average systolic blood pressure (SBP) \<150 and diastolic blood pressure (DBP) \<90 mmHg
* Have quantified proteinuria -- urine albumin/creatinine ratio of \> 17 mg/g (men) and \>25 mg/g (women) (i.e. at least microalbuminuria).
* Participants must be on stable doses of antihypertensive, hypoglycemic, and lipid lowering medications for a minimum of two months prior to randomization. Participants must agree to stay on stable doses of diabetes, antihypertensive and lipid medication for the duration of the study.

Exclusion Criteria

* Use of insulin
* Use of fish oil supplements or are unwilling to stop fish oil supplements one month prior to randomization and refrain from the supplements during the study
* Stage 4 or stage 5 CKD or a screening urine protein/creatinine ratio of \>2.5.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Edgar R. Miller, III

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Edgar R Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins ProHealth, 1849 Gwynn Oak Ave

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Miller ER 3rd, Juraschek SP, Anderson CA, Guallar E, Henoch-Ryugo K, Charleston J, Turban S, Bennett MR, Appel LJ. The effects of n-3 long-chain polyunsaturated fatty acid supplementation on biomarkers of kidney injury in adults with diabetes: results of the GO-FISH trial. Diabetes Care. 2013 Jun;36(6):1462-9. doi: 10.2337/dc12-1940. Epub 2012 Dec 28.

Reference Type DERIVED
PMID: 23275364 (View on PubMed)

Other Identifiers

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1R21DK080372

Identifier Type: NIH

Identifier Source: org_study_id

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