DiabetesPhase 3NCT01092390
Go Fish: Omega-3 Fatty Acid Supplementation in Diabetes-Related Kidney Disease
A Phase 3 study testing Lovaza (fish oil) in people with Diabetes, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Lovaza (fish oil)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to May 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins ProHealth, 1849 Gwynn Oak Ave
Baltimore, Maryland, 21205
About this study
Official title: "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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- Lovaza (fish oil)
- Keywords
- randomized trial, omega three fatty acids
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lovaza (fish oil)Dietary supplement
Also called fish oil (generic), omega three fattay acids (generic)
4 grams per day
| Study group | Role | What they receive |
|---|---|---|
| Lovaza | Experimental | 4 grams per day Receives: Dietary Supplement: Lovaza (fish oil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: end of 2 six week periods (crossover)
Secondary outcomes (1)
Biomarkers of oxidation and inflammation
To determine the effects of omega-3 supplements on markers of oxidations (urine isoprostanes) and inflammation (serum C-reactive protein (hsCRP), RBC fatty acids .
Measured: end of 2 six week periods (crossover)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Edgar R. Miller, III, Johns Hopkins University
- Investigators
- Edgar R Miller, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092390
- Sponsor's protocol ID
- 1R21DK080372
- Status last verified
- Apr 2012
- First submitted
- 23 Mar 2010
- Last updated
- 30 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23275364
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Go Fish"Omega-3 Fatty Acid Supplementation in Diabetic Kidney Disease
- ClinicalTrials.gov ID
- NCT01092390
- Acronym / sponsor ID
- 1R21DK080372
- Conditions
- Diabetes
- Keywords
- randomized trial, omega three fatty acids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Mar 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 24 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lovaza | Experimental | Dietary Supplement: Lovaza (fish oil)4 grams per day |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lovaza (fish oil)Also: fish oil (generic), omega three fattay acids (generic)4 grams per day | Dietary supplement | Lovaza |
Primary outcome
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).
1 secondary outcome
Biomarkers of oxidation and inflammation
Time frame: end of 2 six week periods (crossover)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2012.
- Derived from this study: PubMed 23275364Miller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edgar R Miller, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lovaza (fish oil) in people with Diabetes, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urine protein excretion (time frame: end of 2 six week periods (crossover)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01092390, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2012.