Abstract
Background: Brain microstructural changes in white matter (WM) and gray matter (GM) of type 2 diabetes mellitus (T2DM) patients can be explained using Diffusion Tensor Imaging (DTI) method. Increased oxidative stress has been recognized the key factor in T2DM induce neural damage. Rutin flavonoid plays protective roles in several oxidative stress-mediated neurodegenerative disorders. So, the effects of rutin on WM and GM continuous changes in T2DM patients requires to be more investigated.Method: We will conduct a 3 months, double-blind, randomized controlled clinical trial to examine the effects of rutin supplementation on WM and GM changes in 26 T2DM cases. The intervention group (n=13) and the control group (n=13) will receive one tablet of 1 g rutin/day and one tablet of 1 g placebo/day after meals, respectively. Before and after the intervention, DTI will perform at 1.5 Tesla, followed by an analysis employing tract-based spatial statistics (TBSS) to explore the changes in fractional anisotropy (FA), mean diffusivity (MD), axial diffusivity (λ1), and radial diffusivity (λ23) among the rutin and placebo treated groups. A receiver operating characteristic (ROC) test will use to evaluate the performance of DTI criteria for cutting off the two T2DM groups. Discussion: We will demonstrate the diverse influences of rutin supplementation on WM and GM integrity on T2DM patients. Since, rutin may regulate neurotoxicity, oxidative stress, inflammatory reaction and nitric oxide production in nervous system; for the first time, the effects of rutin on WM and GM alterations will be evaluated by DTI in T2DM patients. Trial registration: Iran Clinical Trials Registry, registration number: IRCT20151128025274N6. Registered on 10 January 2021, https://fa.irct.ir/user/trial/53283/view