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

April 27, 2012 updated by: Edgar R. Miller, III, Johns Hopkins University

"Go Fish"Omega-3 Fatty Acid Supplementation in Diabetic Kidney Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins ProHealth, 1849 Gwynn Oak Ave

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lovaza
4 grams per day
Dietary supplement: Lovaza (fish oil)
4 grams per day
Other Names:
  • fish oil (generic)
  • omega three fattay acids (generic)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
urine protein excretion
Time Frame: 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).
end of 2 six week periods (crossover)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers of oxidation and inflammation
Time Frame: 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 .
end of 2 six week periods (crossover)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Edgar R Miller, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

March 23, 2010

First Submitted That Met QC Criteria

March 23, 2010

First Posted (Estimate)

March 24, 2010

Study Record Updates

Last Update Posted (Estimate)

April 30, 2012

Last Update Submitted That Met QC Criteria

April 27, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R21DK080372 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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