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Study protocol of a randomized controlled clinical trial investigating the effects of omega-3 supplementation on endothelial function, vascular structure, and metabolic parameters in adolescents with type 1 diabetes. | LitMetric

AI Article Synopsis

  • Type 1 diabetes significantly affects endothelial function, vascular structure, and metabolic health, prompting interest in omega-3 as a potential supportive therapy to improve these areas.* -
  • A randomized clinical trial will involve 60 adolescents with type 1 diabetes, who will receive either omega-3 (600 mg/day) or a placebo for 12 weeks while their health parameters are monitored.* -
  • The study aims to assess whether omega-3 can reduce inflammation, oxidative stress, and improve metabolic functions related to type 1 diabetes, with ethical approval secured for the trial.*

Article Abstract

Background: Type 1 diabetes is a main health burden with several related comorbidities. It has been shown that endothelial function, vascular structure, and metabolic parameters are considerably disrupted in patients with type 1 diabetes. Omega-3 as an adjuvant therapy may exert profitable effects on type 1 diabetes and its complications by improving inflammation, oxidative stress, immune responses, and metabolic status. Because no randomized clinical trial has examined the effects of omega-3 consumption in children and adolescents with type 1 diabetes; the present study aims to close this gap.

Methods: This investigation is a randomized clinical trial, in which sixty adolescents with type 1 diabetes will be randomly assigned to receive either omega-3 (600 mg/day) or placebo capsules for 12 weeks. Evaluation of anthropometric parameters, flow-mediated dilation (FMD) as an endothelial function marker, carotid intima-media thickness (CIMT) as a vascular structure marker, proteinuria, biochemical factors including glycemic and lipid profile, blood urea nitrogen (BUN), creatinine, high-sensitivity C-reactive protein (hs-CRP), and erythrocyte sedimentation rate (ESR), as well as blood pressure will be done at the baseline and end of the trial. Also, dietary intake and physical activity will be assessed throughout the study. Statistical analysis will be performed using the SPSS software (Version 24), and P < 0.05 will be considered statistically meaningful.

Discussion: It is hypothesized that omega-3 supplementation may be beneficial for the management of type 1 diabetes and its complications by reducing inflammation and oxidative stress and also modulating immune responses and glucose and lipid metabolism through various mechanisms. The present study aims to investigate any effect of omega-3 on patients with type 1 diabetes.

Ethical Aspects: This trial received approval from Medical Ethics Committee of Iran University of Medical Sciences, Tehran, Iran (IR.IUMS.REC.1400.070).

Trial Registration: Iranian Registry of Clinical Trials IRCT20210419051010N1 . Registered on 29 April 2021.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8710929PMC
http://dx.doi.org/10.1186/s13063-021-05930-1DOI Listing

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