Effect of Omega-3 Fatty Acids on Eye Blood Vessels in Type 1 Diabetes (O3RETINA)

University of Faisalabad

Status: Enrolling

Conditions: Type 1 Diabetes; Omega 3 Fatty Acids; Diabetic Retinopathy

Treatments: Dietary Supplement: Omega 3 Fish Oil supplements

Study type: Interventional

Funder types: Other

Identifiers

NCT07255326

1174/CH-UCHS (Other Identifier)

NIDA_OMEGA3_T1D_RETINA_001

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 10 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Diagnosis of Type 1 Diabetes Age between 10 and 45 years Duration of diabetes ≥ 2 years Mild to moderate diabetic retinopathy allowed (based on fundus examination)

Exclusion criteria

Presence of any ocular disease other than diabetic retinopathy Use of medications that may affect retinal vascular measurements or visual function outcomes Presence of systemic diseases other than diabetes (e.g., uncontrolled hypertension, autoimmune diseases) History of ocular surgery within the past 6 months Current participation in another interventional clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Omega-3 Supplement Group

Experimental group

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.

Treatment:

Dietary Supplement: Omega 3 Fish Oil supplements

Omega-3 Control Group

Placebo Comparator group

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.

Treatment:

Dietary Supplement: Omega 3 Fish Oil supplements