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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Edgar R. Miller, III, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01092390
First received: March 23, 2010
Last updated: April 27, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Diabetes
Dietary Supplement: Lovaza (fish oil)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "Go Fish"Omega-3 Fatty Acid Supplementation in Diabetic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • urine protein excretion [ Time Frame: end of 2 six week periods (crossover) ] [ Designated as safety issue: No ]
    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:
  • Biomarkers of oxidation and inflammation [ Time Frame: end of 2 six week periods (crossover) ] [ Designated as safety issue: No ]
    To determine the effects of omega-3 supplements on markers of oxidations (urine isoprostanes) and inflammation (serum C-reactive protein (hsCRP), RBC fatty acids .


Enrollment: 31
Study Start Date: March 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092390

Locations
United States, Maryland
Johns Hopkins ProHealth, 1849 Gwynn Oak Ave
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
GlaxoSmithKline
Investigators
Principal Investigator: Edgar R Miller, MD Johns Hopkins University
  More Information

No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Edgar R. Miller, III, PI, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01092390     History of Changes
Other Study ID Numbers: 1R21DK080372
Study First Received: March 23, 2010
Last Updated: April 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
randomized trial
omega three fatty acids

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetic Nephropathies
Kidney Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on August 21, 2014