The Effect of Omega-3 Supplementation on Nerve Structure and Function in Type 1 Diabetes
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|ClinicalTrials.gov Identifier: NCT02034266|
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : April 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Dietary Supplement: Omega-3 supplementation||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||open label study with no placebo.|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
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.
Dietary Supplement: Omega-3 supplementation
5 mL twice daily, administered under the tongue
Other Name: Auum Omega-3 oil
- 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).
- 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.
- 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.
- 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.
- Vibration Perception Threshold [ Time Frame: Baseline and 12 months ]Vibration perception threshold will be performed using the Neurothesiometer to evaluate sensory nerve function.
- Cooling Detection Threshold Testing [ Time Frame: Baseline and 12 months ]Cooling detection threshold testing will evaluate peripheral sensory nerve function.
- Omega-3 status [ Time Frame: Baseline, 4, 8 and 12 months ]Red blood cell omega-3 content will be determined using gas-flame chromatography.
- Heart Rate Variability [ Time Frame: Baseline and 12 months ]
- R-R interval [ Time Frame: Baseline and 12 months ]
- Glycated hemoglobin A1c [ Time Frame: Baseline and 12 months ]Measure of glycemic control
- Serum lipids [ Time Frame: Baseline and 12 months ]
- Thyroid stimulating hormone [ Time Frame: Baseline and 12 months ]
- Creatinine [ Time Frame: Baseline and 12 months ]
- Vitamin B12 [ Time Frame: Baseline and 12 months ]
- Serum Folate [ Time Frame: Baseline and 12 months ]
- Uric acid [ Time Frame: Baseline and 12 months ]
- Urinary albumin excretion [ Time Frame: Baseline and 12 months ]
- Serum protein electrophoresis [ Time Frame: Baseline and 12 months ]
- Serum C-reactive protein [ Time Frame: Baseline and 12 months ]
- Serum fatty acid profile [ Time Frame: Baseline and 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034266
|University Health Network, Division of Neurology, Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||Vera Bril, MD||University Health Network, Toronto|