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

NCT ID: NCT02034266

Last Updated: 2017-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-08-31

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.

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Omega-3 supplementation

Intervention Type: DIETARY_SUPPLEMENT

5 mL twice daily, administered under the tongue

Interventions

Omega-3 supplementation

5 mL twice daily, administered under the tongue

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Auum Omega-3 oil

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Diabetes Association

OTHER

Sponsor Role: collaborator

Eduardo Ng

OTHER

Sponsor Role: lead

Responsible Party

Eduardo Ng

Clinical Research Manager

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Vera Bril, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

University Health Network, Division of Neurology, Toronto General Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 28515269 (View on PubMed)

Other Identifiers

T1DM Omega-3 study

Identifier Type: -

Identifier Source: org_study_id