NCT01092390

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_3 diabetes

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

April 30, 2012

Status Verified

April 1, 2012

Enrollment Period

1.2 years

First QC Date

March 23, 2010

Last Update Submit

April 27, 2012

Conditions

Diabetes

Keywords

randomized trialomega three fatty acids

Outcome Measures

Primary Outcomes (1)

  • urine protein excretion

    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 Outcomes (1)

  • Biomarkers of oxidation and inflammation

    end of 2 six week periods (crossover)

Study Arms (1)

Lovaza

EXPERIMENTAL

4 grams per day

Dietary Supplement: Lovaza (fish oil)

Interventions

Lovaza (fish oil)DIETARY_SUPPLEMENT

4 grams per day

Also known as: fish oil (generic), omega three fattay acids (generic)
Lovaza

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins ProHealth, 1849 Gwynn Oak Ave

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

  • 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.

    PMID: 23275364DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

OmacorFish OilsDrugs, Generic

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

OilsLipidsPharmaceutical Preparations

Study Officials

  • Edgar R Miller, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

March 23, 2010

First Posted

March 24, 2010

Study Start

March 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

April 30, 2012

Record last verified: 2012-04

Locations

US(1)