Omega-3 supplements for improving peripheral nerve health in type-1 diabetes

Phase 2

Completed

• Conditions: Type-1 diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12618000705280
• Lead Sponsor: The University of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-30
• Study Completion: 2020-03-10
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 43

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.)

Study & Design

• Study Type: Interventional
• Study Design: Not specified