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

Phase 3

Completed

• Conditions: Diabetes
• Interventions: Dietary Supplement: Lovaza (fish oil)

• Registration Number: NCT01092390
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-23
• Study First Submitted QC: 2010-03-23
• Study First Posted: 2010-03-24
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-27
• Last Update Posted: 2012-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

• Major exclusion criteria will be poorly controlled diabetes (Hemoglobin A1c >9%)
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lovaza	Lovaza (fish oil)	4 grams per day

Primary Outcome Measures

Name	Time	Method
urine protein excretion	end of 2 six week periods (crossover)	Primary Specific Aim To determine the effects of omega-3 fatty acid supplementation on urine protein excretion and surrogate markers of kidney injury including: serum beta-microglobulin and cystatin C (biomarkers of GFR) and urine neutrophil gelatinase-associated lipocain (NGAL a.k.a. lipocalin-2), kidney injury molecule-1 (KIM-1), and interleukin-18 (IL-18) (biomarkers of tubular reabsorption impairment and inflammation).

Secondary Outcome Measures

Name	Time	Method
Biomarkers of oxidation and inflammation	end of 2 six week periods (crossover)	To determine the effects of omega-3 supplements on markers of oxidations (urine isoprostanes) and inflammation (serum C-reactive protein (hsCRP), RBC fatty acids .

Trial Locations

Locations (1)

Johns Hopkins ProHealth, 1849 Gwynn Oak Ave; 🇺🇸 Baltimore, Maryland, United States