NCT02034266

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2014

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

January 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

2.6 years

First QC Date

January 9, 2014

Last Update Submit

April 26, 2017

Conditions

Type 1 Diabetes

Keywords

Type one diabetesnerve damageneuropathyomega-3 fatty acidsupplementationnutrition

Outcome Measures

Primary Outcomes (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).

    Baseline and 12 months

Secondary Outcomes (8)

  • Nerve Conduction Studies

    Baseline and 12 months

  • Corneal Nerve Fibre Length

    4 months and 8 months

  • Laser Doppler Imaging Flare (LDI Flare) sympathetic skin response

    Baseline and 12 months

  • Vibration Perception Threshold

    Baseline and 12 months

  • Cooling Detection Threshold Testing

    Baseline and 12 months

  • +3 more secondary outcomes

Other Outcomes (11)

  • Glycated hemoglobin A1c

    Baseline and 12 months

  • Serum lipids

    Baseline and 12 months

  • Thyroid stimulating hormone

    Baseline and 12 months

  • +8 more other outcomes

Study Arms (1)

Omega-3 supplementation

EXPERIMENTAL

Participants 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.

Dietary Supplement: Omega-3 supplementation

Interventions

Omega-3 supplementationDIETARY_SUPPLEMENT

5 mL twice daily, administered under the tongue

Also known as: Auum Omega-3 oil
Omega-3 supplementation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A. 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

You may not qualify if:

  • A. 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).
  • H. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network, Division of Neurology, Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 28515269DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Vera Bril, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: open label study with no placebo.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Research Manager

Study Record Dates

First Submitted

January 9, 2014

First Posted

January 13, 2014

Study Start

January 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

April 28, 2017

Record last verified: 2017-04

Locations

CA(1)