Metabolic and genetic response to probiotics supplementation in patients with diabetic nephropathy: a randomized, double-blind, placebo-controlled t

 This  study  was  carried out  to  evaluate the  effects  of  probiotics administration on  the  metabolic and genetic profiles  in patients with  diabetic nephropathy (DN). This was  a randomized, placebo-controlled clinical  trial  with   homeostasis  model  of  assessment-estimated  insulin  resistance  (HOMA-IR) as  the primary  and  other metabolic profiles,  and  biomarkers of inflammation and  oxidative  stress as the  secondary  outcomes. This  randomized, double-blind, placebo-controlled  clinical  trial  was  performed on  60 patients with  DN. The  patients were  randomly assigned into  two  groups to  receive either 8 × 109  CFU day−1  probiotic supplements or placebo (n = 30 in each group) for 12 weeks. Fasting  blood was collected at the  baseline and  end  of intervention to measure glycemic control, lipid profiles,  biomarkers of inflammation and  oxidative  stress. Multiple linear  regression models were  used to  assess the  treatment effects on  the  outcomes  adjusting for  confounding variables.  Probiotics supplementation, compared  with  the placebo, resulted in a significant reduction  in fasting  plasma glucose (P =  0.01), serum insulin  concen- trations (P = 0.01) and HOMA-IR (P = 0.007),  and a significant increase in the  quantitative insulin sensitivity check index  (P = 0.04).  Additionally, compared with the  placebo, probiotic intake  resulted in a significant reduction in  triglycerides  (P =  0.001)   and  total-/HDL-cholesterol  ratio  (P <  0.001),   and  a  significant increase in  HDL-cholesterol levels  (P <  0.001).   Supplementation with  probiotics, compared  with  the placebo, was  associated with  a  significant reduction  in  high-sensitivity C-reactive protein (P =  0.001), malondialdehyde (P < 0.001)  and  advanced glycation end  products (P < 0.001),  and  a significant elevation in plasma total  glutathione (P < 0.001).  Overall, our study  indicated that  probiotics supplementation had beneficial effects on glycemic control and markers of cardio-metabolic risk.