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Type 1 DiabetesPhase 2NCT02034266

The Effect of Omega-3 Supplementation on Nerve Structure and Function in Type 1 Diabetes

A Phase 2 study testing Omega-3 supplementation in people with Type 1 Diabetes, run by Eduardo Ng at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Nerves are made of different fats including omega-3s and omega-6s; however, dietary intakes of omega-6s are very high and omega-3 intakes are very low. We hypothesize that omega-3 supplementation will stop diabetes related changes in cornea nerve structure in patients with type 1 diabetes to stop the development of… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes
What is being tested?
Omega-3 supplementation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCanada
Study dates
Jan 2014to Aug 2016
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients of any gender or race aged 18 or above B. Type 1 diabetes mellitus as defined by the 2008 Canadian Diabetes Association C. Toronto Clinical Neuropathy Score ≥1 D. Ability to understand and cooperate with study procedures

Who cannot join

  • Current eye infection or damage of cornea B. Severe movement disorder C. History of allergy to proparacaine (the ocular topical anaesthetic used for the corneal confocal microscopy exam) D. Inability to sit and lie supine comfortably for 45-60 minutes E. Major medical or psychiatric illness that would preclude successful participation in the study F. Unwillingness to sign informed consent. G. Confirmed neuropathy secondary to non-diabetic causes (examples include polyneuropathy owing to alcohol abuse, B12 deficiency, folate deficiency, chronic renal failure, hypothyroidism, or neurotoxic drug use such as chemotherapy).
  • Current or previous regular (>3 times per week) consumption of omega-3 supplements within the past month I. Consistently consuming fish >2 times per week in the past month J. Performing regular exercise >3 times per week in the past 3 months

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University Health Network, Division of Neurology, Toronto General Hospital

    Toronto, Ontario, M5G 2C4

Other trials in Canada

About this study

Official title: Phase 2 Study of the Effects of Omega-3 Fatty Acid Supplementation on Nerve Structure and Function in Type 1 Diabetes Mellitus - A Clinical Pilot Study

Nerves are made of different fats including omega-3s and omega-6s; however, dietary intakes of omega-6s are very high and omega-3 intakes are very low. We hypothesize that omega-3 supplementation will stop diabetes related changes in cornea nerve structure in patients with type 1 diabetes to stop the development of nerve injury associated with future risk of neuropathy, and reflect changes in the degree of nerve injury over time. As such, we anticipate that patients in the study will maintain Corneal Nerve Fiber Length (CNFL), the primary outcome measure.

Read the detailed description

This study will test the use of an omega-3 supplement as a potential way to stop nerve damage that has been observed in individuals with type 1 diabetes Nerves supply signals to all structures in the body and take signals back to the spinal cord and brain. Both small and large nerve fibres can be affected in disease states, such as diabetes. Since defects of small nerve fibre activity have important consequences (painful symptoms, erectile dysfunction, cardiac rhythm disturbances, bladder and gastrointestinal dysfunction), it is important to determine new ways to maintain their function to help individuals maintain a high quality of life.

Until now, researchers have only tested the effect of omega-3 supplementation in animals with diabetes and have found this nutrient to lessen nerve damage while maintaining the function of nerves. However, there has not been any research on the use of omega-3s on nerve structure and function in humans with type 1 diabetes.

Current standard of care for type 1 diabetes is to manage glycemic control and any painful symptoms through medication. The use of omega-3 supplements for prevent or limit nerve damage in diabetes is not within the current standard of care. In this study omega-3 supplementation is experimental and has been approved by Health Canada for use in this study.

Conditions
Type 1 Diabetes
Being tested
Omega-3 supplementation
Keywords
Type one diabetes, nerve damage, neuropathy, omega-3 fatty acid, supplementation, nutrition
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omega-3 supplementationDietary supplement

    Also called Auum Omega-3 oil

    5 mL twice daily, administered under the tongue

Study groups in NCT02034266
Study groupRoleWhat they receive
Omega-3 supplementationExperimentalParticipants will take an oral 5 mL serving (1 tbsp) of mammalian omega-3 seal oil (375 mg EPA, 280 mg DPA and 510 mg DHA) (Auum Inc., Timmons, On) twice daily. Total daily essential fatty acid load - 2330 mg.
Receives: Dietary Supplement: Omega-3 supplementation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in corneal nerve fibre length

    Participants will undergo examination of nerve fibres adjacent to the Bowman's layer of the cornea in both eyes using the Rostock Cornea Module of the Heidelberg Tomograph III (Heidelberg Engineering, Smithfield RI, USA) to determine corneal IVCM corneal nerve fibre length (CNFL).

    Measured: Baseline and 12 months

Secondary outcomes (8)

  1. Nerve Conduction Studies

    Nerve conduction studies will be conducted using standardized testing of the left median, ulnar, peroneal, and sural sensory nerves for signal amplitude and conduction velocity.

    Measured: Baseline and 12 months

  2. Corneal Nerve Fibre Length

    Interim measures of CNFL will be measured as a secondary outcome to track progressive changes with supplementation.

    Measured: 4 months and 8 months

  3. Laser Doppler Imaging Flare (LDI Flare) sympathetic skin response

    The purpose of this measure is to document, separate from the corneal IVCM parameters, small nerve fiber function. LDI Flare measurement will be conducted on MoorLDI2 Laser Doppler blood perfusion imager.

    Measured: Baseline and 12 months

  4. Vibration Perception Threshold

    Vibration perception threshold will be performed using the Neurothesiometer to evaluate sensory nerve function.

    Measured: Baseline and 12 months

  5. Cooling Detection Threshold Testing

    Cooling detection threshold testing will evaluate peripheral sensory nerve function.

    Measured: Baseline and 12 months

  6. Omega-3 status

    Red blood cell omega-3 content will be determined using gas-flame chromatography.

    Measured: Baseline, 4, 8 and 12 months

  7. Heart Rate Variability

    Measured: Baseline and 12 months

  8. R-R interval

    Measured: Baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

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 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
open label study with no placebo.
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02034266
Sponsor's protocol ID
T1DM Omega-3 study
Status last verified
Apr 2017
First submitted
9 Jan 2014
Last updated
28 Apr 2017
Results posted
No
Data monitoring committee
No

Publications

  • Lewis EJH, Perkins BA, Lovblom LE, Bazinet RP, Wolever TMS, Bril V. Effect of omega-3 supplementation on neuropathy in type 1 diabetes: A 12-month pilot trial. Neurology. 2017 Jun 13;88(24):2294-2301. doi: 10.1212/WNL.0000000000004033. Epub 2017 May 17.

    PubMed 28515269

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Omega-3 supplementation in people with Type 1 Diabetes, run by Eduardo Ng at 1 site in Canada.

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 1 inclusion and 2 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 28 Apr 2017. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Change in corneal nerve fibre length (time frame: Baseline and 12 months). 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 NCT02034266, 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 28 Apr 2017.

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