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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University Health Network, Toronto
Sponsor:
Collaborator:
Canadian Diabetes Association
Information provided by (Responsible Party):
Eduardo Ng, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT02034266
First received: January 9, 2014
Last updated: May 26, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Dietary Supplement: Omega-3 supplementation
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Change in corneal nerve fibre length [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Nerve Conduction Studies [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Vibration perception threshold will be performed using the Neurothesiometer to evaluate sensory nerve function.

  • Cooling Detection Threshold Testing [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Cooling detection threshold testing will evaluate peripheral sensory nerve function.

  • Omega-3 status [ Time Frame: Baseline, 4, 8 and 12 months ] [ Designated as safety issue: No ]
    Red blood cell omega-3 content will be determined using gas-flame chromatography.

  • Heart Rate Variability [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • R-R interval [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Glycated hemoglobin A1c [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Measure of glycemic control

  • Serum lipids [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Thyroid stimulating hormone [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Creatinine [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Vitamin B12 [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Serum Folate [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Uric acid [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Urinary albumin excretion [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Serum protein electrophoresis [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Serum C-reactive protein [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Serum fatty acid profile [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02034266

Locations
Canada, Ontario
University Health Network, Division of Neurology, Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Eduardo Ng    416-340-3898    Eduardo.Ng@uhn.ca   
Principal Investigator: Vera Bril, MD         
Sponsors and Collaborators
Eduardo Ng
Canadian Diabetes Association
Investigators
Principal Investigator: Vera Bril, MD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: Eduardo Ng, Clinical Research Manager, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02034266     History of Changes
Other Study ID Numbers: T1DM Omega-3 study
Study First Received: January 9, 2014
Last Updated: May 26, 2014
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Type one diabetes
nerve damage
neuropathy
omega-3 fatty acid
supplementation
nutrition

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014