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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
82
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.
Children Hospital Lahore and Ali Fatima Hospital
Lahore, Punjab Province, Pakistan
Change in Retinal Artery Diameter
Change in central retinal artery equivalent measured from fundus photographs using OCTA
Time frame: 3 Months 6 Months 9 Months
Change in Retinal Vein Diameter
Change in central retinal vein equivalent measured from fundus photographs using OCTA
Time frame: 3 Months 6 Months 9 Months
Change in Best-Corrected Visual Acuity
Change in BCVA measured using the logMAR chart at 4 meters
Time frame: 3 Months 6 Months 9 Months
Change in Contrast Sensitivity
Change in contrast sensitivity measured using the Pelli-Robson chart
Time frame: 3 Months 6 Months 9 Months
Change in HbA1c
Change in glycosylated hemoglobin (HbA1c) measured through laboratory blood testing
Time frame: 3 Months 6 Months 9 Months
Change in Fasting Blood Glucose
Change in Random blood Sugar measured through venous blood sampling
Time frame: 3 Months 6 Months 9 Months
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