- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02034266
The Effect of Omega-3 Supplementation on Nerve Structure and Function in Type 1 Diabetes
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2C4
- University Health Network, Division of Neurology, Toronto General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Omega-3 supplementation
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.
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5 mL twice daily, administered under the tongue
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in corneal nerve fibre length
Time Frame: Baseline and 12 months
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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).
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Baseline and 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nerve Conduction Studies
Time Frame: Baseline and 12 months
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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.
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Baseline and 12 months
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Corneal Nerve Fibre Length
Time Frame: 4 months and 8 months
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Interim measures of CNFL will be measured as a secondary outcome to track progressive changes with supplementation.
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4 months and 8 months
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Laser Doppler Imaging Flare (LDI Flare) sympathetic skin response
Time Frame: Baseline and 12 months
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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.
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Baseline and 12 months
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Vibration Perception Threshold
Time Frame: Baseline and 12 months
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Vibration perception threshold will be performed using the Neurothesiometer to evaluate sensory nerve function.
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Baseline and 12 months
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Cooling Detection Threshold Testing
Time Frame: Baseline and 12 months
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Cooling detection threshold testing will evaluate peripheral sensory nerve function.
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Baseline and 12 months
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Omega-3 status
Time Frame: Baseline, 4, 8 and 12 months
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Red blood cell omega-3 content will be determined using gas-flame chromatography.
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Baseline, 4, 8 and 12 months
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Heart Rate Variability
Time Frame: Baseline and 12 months
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Baseline and 12 months
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R-R interval
Time Frame: Baseline and 12 months
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Baseline and 12 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glycated hemoglobin A1c
Time Frame: Baseline and 12 months
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Measure of glycemic control
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Baseline and 12 months
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Serum lipids
Time Frame: Baseline and 12 months
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Baseline and 12 months
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Thyroid stimulating hormone
Time Frame: Baseline and 12 months
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Baseline and 12 months
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Creatinine
Time Frame: Baseline and 12 months
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Baseline and 12 months
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Vitamin B12
Time Frame: Baseline and 12 months
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Baseline and 12 months
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Serum Folate
Time Frame: Baseline and 12 months
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Baseline and 12 months
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Uric acid
Time Frame: Baseline and 12 months
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Baseline and 12 months
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Urinary albumin excretion
Time Frame: Baseline and 12 months
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Baseline and 12 months
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Serum protein electrophoresis
Time Frame: Baseline and 12 months
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Baseline and 12 months
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Serum C-reactive protein
Time Frame: Baseline and 12 months
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Baseline and 12 months
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Serum fatty acid profile
Time Frame: Baseline and 12 months
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Baseline and 12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Vera Bril, MD, University Health Network, Toronto
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- T1DM Omega-3 study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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