Diabetic Retinopathy, Omega 3 Fatty Acids, Type 1 Diabetes
Conditions
Keywords
Diabetic retinopathy, retinal microvasculature, type 1 diabetes, retinal blood flow
Brief summary
This double-blind, placebo-controlled randomized clinical trial evaluates the effects of omega-3 fatty acid supplementation on retinal vascular structure and function in children and adolescents with type 1 diabetes. The study compares omega-3 supplementation with placebo to assess changes in retinal microvascular parameters, retinal blood flow, visual function, and systemic biomarkers over time, as well as the safety and tolerability of supplementation during the study period.
Detailed description
Type 1 diabetes mellitus is associated with early retinal microvascular and hemodynamics alterations that may precede clinically visible diabetic retinopathy. Omega-3 fatty acids have been reported to exert anti-inflammatory, vasoprotective, and neuroprotective effects, and may therefore help preserve retinal vascular integrity and ocular blood flow in individuals with diabetes. This randomized, double-blind, placebo-controlled clinical trial was designed to evaluate the effects of omega-3 supplementation on retinal vascular structure and function in children with type 1 diabetes. Participants were randomized to receive either omega-3 supplementation or placebo and were followed longitudinally over the study period. Serial ophthalmic and systemic assessments were performed to examine changes in retinal microvascular parameters, retinal blood flow, visual function, and selected systemic biomarkers.
Interventions
DIETARY_SUPPLEMENTOmega 3 Fish Oil supplements
Participants received one oral omega-3 fish oil capsule daily for the duration of the study. Each capsule contained 1000 mg fish oil, providing EPA 180 mg and DHA 120 mg.
OTHERPlacebo
Participants received one oral placebo capsule daily, matched in appearance to the omega-3 supplement but containing no active omega-3 fatty acids, for the duration of the study.
Sponsors
University of Faisalabad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This was a double-blind, placebo-controlled randomized clinical trial. Participants, care providers, investigators, and outcome assessors were blinded to treatment allocation throughout the study period.
Intervention model description
Participants will be randomly assigned to either the omega-3 group or a placebo group. Both groups will attend regular eye exams every three months to monitor changes in retinal blood vessels. Outcomes will be compared between the two groups to assess the effects of omega-3 supplementation
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
Type 1 Diabetes with earliest changes i.e. microaneurysms or changes in retinal vessels
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Retinal Artery Diameter | Baseline, 3 Months 6 Months 9 Months | Change in retinal artery measured using OCTA |
| Change in Retinal Vein Diameter | Baseline, 3 Months 6 Months 9 Months | Change in retinal vein diameter measured using OCTA |
| Change in Foveal Avascular Zone (Area, Perimeter and Circulatory) | Baseline, 3 Months, 6 Months, 9 Months | To measure the change in Foveal Avascular Zone parameter by using OCTA. |
| Central Retinal Artery (PSV, EDV, RI). Central retinal vein (Mean Velocity), Ophthalmic Artery (PSV, EDV, RI), Posterior Ciliary Artery (PSV, EDV, RI) | Baseline, 3 Months, 6 Months, 9 Months | Central Retinal Artery (PSV, EDV, RI). Central retinal vein (Mean Velocity), Ophthalmic Artery (PSV, EDV, RI), Posterior Ciliary Artery (PSV, EDV, RI) blood flow is measured by doppler ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | Baseline, 3 Months 6 Months 9 Months | Change in VA measured using the logMAR chart at 4 meters |
| Contrast Sensitivity | Baseline, 3 Months 6 Months 9 Months | Change in contrast sensitivity measured using the Pelli-Robson chart |
| Blood Sugar Random, Glycosylated hemoglobin (HbA1c), Lipid Profile (Total cholesterol, HDL, LDL, Triglycerides) | Baseline, 3 Months 6 Months 9 Months | Change in Blood Sugar Random, glycosylated hemoglobin (HbA1c), Lipid Profile (Total cholesterol, HDL, LDL, Triglycerides) measured through venous blood sampling |
Countries
Pakistan
Outcome results
None listed