None listed
Conditions
Brief summary
Diabetic neuropathy is the most common complication of diabetes mellitus, affecting >50% of individuals with the condition. The Diabetes Control and Complications Trial demonstrated that intensive blood glucose control could reduce the incidence of neuropathy and potentially slow progressive nerve damage; however, there are currently no clinical therapies for attenuating the onset or progression of neuropathy. Omega-3 supplements have potential general health benefits, however their effect on peripheral nerves is currently unknown. There is growing scientific evidence that dietary supplementation with omega-3 essential fatty acids, may be of benefit in improving peripheral nerve integrity. This randomised, double-masked, placebo-controlled clinical trial to assess the effects of a six-month period of supplementation with omega-3 PUFAs on small nerve fibre structure and function, measured both in the eye and the extremities of the body, in individuals with type-1 diabetes. The effects omega-3 supplements will be compared with a control group, who will consume an olive oil supplement. If shown to be effective, omega-3 supplements could be an adjuvant therapy (additional to achieving optimal glucose control), for treating diabetic neuropathy, for which there are currently no other treatments.
Interventions
Arm 1 (Treatment 1): trigylceride long-chain omega-3 oral supplement, twice daily oral capsule, for six months. Dose: EPA: 1180mg + DHA 720mg per day.
Adherence to treatment will be monitored by the analysis of systemic fatty acid profiles at the end of the study, and counting of the return of unused capsules at follow-up visits by an independent researcher.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Provision of written informed consent to participate Confirmed diagnosis of type-1 diabetes for at least five years Ability to understand and follow study instructions, and intent to complete all study visits
Exclusion criteria
Uncontrolled systemic disease (other than sub-optimally controlled diabetes mellitus) Confirmed neuropathy secondary to causes other than diabetes Co-morbid ocular pathology (e.g., ocular infection, intra-ocular inflammation) or presence of corneal abnormalities that could distrupt normal corneal nerve morphology Known allergy to or previous reaction to any ocular agents used in the study (i.e., ocular anaesthetics, sodium fluorescein, ocular mydriatics) Scheduled or planned ocular surgery or procedure over the course of the study Any history of hard (rigid) contact lens wear Use of autologous serum eye drops within three (3) months of enrolment, or anticipated use during the course of the study; Known or suspected allergy to fish/seafood, nuts, oil or gelatin Current or previous regular consumption of any omega-3 oral supplements (>3 times/week) in the three months preceding Visit 1 A systemic medical condition where omega-3 supplements are contraindicated (e.g., bleeding disorders, diabetes, atrial fibrillation, familial immunocompromise, adenomatous polyposis, liver disease.)
Outcome results
None listed