NCT07255326

Effect of Omega-3 Fatty Acids on Eye Blood Vessels in Type 1 Diabetes

Role of Omega-3 Fatty Acids in Modulating Retinal Microvascular Changes in Type 1 Diabetes

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Faisalabad · Academic / Other
• Sex: All
• Age: 10 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The aim of this clinical trial is to learn if omega-3 fatty acid supplements help maintain healthy blood vessels in the eyes of adults with type 1 diabetes. It will also learn about the safety of omega-3 supplements. The main questions it aims to answer are: Do omega-3 supplements improve the health of retinal blood vessels in adults with type 1 diabetes? Are there any side effects when taking omega-3 supplements? Researchers will compare participants taking omega-3 supplements to a control group (if applicable) to see if the supplements help support retinal blood vessel health. Participants will: Take a daily omega-3 supplement for the duration of the study Attend regular eye exams to monitor changes in the retina Report any side effects or health changes during the study

Detailed description

People with type 1 diabetes are at risk of having changes in microvasculature of the retina, which may impair visual functions with time. This paper examines the potential of daily supplemental intake of omega -3 fatty acids to maintain retinal vascularity and prevent the ocular complications linked to diabetes. The researchers seek to know whether the supplements can protect the eyes and enhance the long-term eye health. The trial participants will consume a daily dose of omega 3 and visit a clinic after every quarterly interval to take ophthalmic tests. In the process of such appointments the research team will examine the health of the retinal and record any vascular changes. Another questionnaire that will be administered to the participants is the one that focuses on adverse events, including mild gastrointestinal discomfort, linked to supplementation. The trial period will take around 12 months. The control cohort will be assigned to the non-supplemented group in order to compare the differences in retinal microvascular health in subjects subjected to omega-3 supplementation. The results although may not have immediate therapeutic value would inform future interventions to prevent or mitigate ocular complications in people with type 1 diabetes.

Conditions

• Diabetic Retinopathy
• Type 1 Diabetes
• Omega 3 Fatty Acids

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Omega 3 Fish Oil supplements	Arm 1 - Omega-3 Supplement Group: Intervention Type: Dietary Supplement Intervention Name: Omega-3 Fatty Acid Supplement Intervention Description: Participants will take one daily capsule containing 1000 mg of combined EPA and DHA. The supplement is taken orally with food. Eye exams will be performed every three months to monitor retinal blood vessel health. Participants will report any side effects such as mild stomach upset. Arm 2 - Placebo / Control Group: Intervention Type: Placebo Intervention Name: Placebo Capsule Intervention Description: Participants will take a daily capsule that looks identical to the omega-3 supplement but contains no active omega-3 fatty acids. Eye exams will be performed every three months to monitor retinal blood vessel health. Participants will report any health changes.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-03-01
• Completion: 2026-07-30
• First posted: 2025-12-01
• Last updated: 2025-12-01

Locations

1 site across 1 country: Pakistan