Skip to main content
OpenTrials
Completed

NCT Number: NCT02034266

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Health Network, Division of Neurology, Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Omega-3 supplementation

Dietary Supplement

5 mL twice daily, administered under the tongue

Other names: Auum Omega-3 oil

Primary outcomes

  1. Change in corneal nerve fibre length

    Time frame: Baseline and 12 months

    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).

Secondary outcomes

  1. Nerve Conduction Studies

    Time frame: Baseline and 12 months

    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.

  2. Corneal Nerve Fibre Length

    Time frame: 4 months and 8 months

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

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

    Time frame: Baseline and 12 months

    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.

  4. Vibration Perception Threshold

    Time frame: Baseline and 12 months

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

  5. Cooling Detection Threshold Testing

    Time frame: Baseline and 12 months

    Cooling detection threshold testing will evaluate peripheral sensory nerve function.

  6. Omega-3 status

    Time frame: Baseline, 4, 8 and 12 months

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

  7. Heart Rate Variability

    Time frame: Baseline and 12 months

  8. R-R interval

    Time frame: Baseline and 12 months

Other outcomes

  1. Glycated hemoglobin A1c

    Time frame: Baseline and 12 months

    Measure of glycemic control

  2. Serum lipids

    Time frame: Baseline and 12 months

  3. Thyroid stimulating hormone

    Time frame: Baseline and 12 months

  4. Creatinine

    Time frame: Baseline and 12 months

  5. Vitamin B12

    Time frame: Baseline and 12 months

  6. Serum Folate

    Time frame: Baseline and 12 months

  7. Uric acid

    Time frame: Baseline and 12 months

  8. Urinary albumin excretion

    Time frame: Baseline and 12 months

  9. Serum protein electrophoresis

    Time frame: Baseline and 12 months

  10. Serum C-reactive protein

    Time frame: Baseline and 12 months

  11. Serum fatty acid profile

    Time frame: Baseline and 12 months

Sponsors and collaborators

Lead sponsor

Eduardo Ng

Other

Collaborators

  • Canadian Diabetes Association

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 13, 2014
Registry last updated
Apr 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.