A Randomized Double-Blind Placebo-Controlled Study on the Safety and Efficacy of Probiotics for Insulin Resistance and Oxidative Stress Markers in Diabetic Patients With End-Stage Renal Disease on Hemodialysis

Background: Chronic kidney disease (CKD) is a progressive loss of kidney function that can lead to end-stage renal disease (ESRD), requiring renal replacement therapy. Patients on chronic hemodialysis are at a higher risk of developing cardiovascular disease. This study aimed to investigate the effect of 12-week probiotic supplementation on insulin resistance, oxidative stress, and lipid profiles in diabetic patients with ESRD undergoing hemodialysis.

Methods: This is a prospective, randomized, parallel-group, double-blind, placebo-controlled study with efficacy parameters including changes in insulin resistance assessed by homeostatic model assessment for insulin resistance (HOMA-IR); oxidative stress markers malondialdehyde (MDA), nitric oxide (NO), and glutathione (GSH); glycemic control (fasting blood sugar (FBS), glycosylated hemoglobin); and lipid profile over 12 weeks of probiotic supplementation in diabetic patients with ESRD on hemodialysis compared to placebo.

Results: The study included a total of 47 subjects, 30 men and 17 women with a mean age of 52.68 years, and observed a significant reduction in HOMA-IR with a mean difference of 0.66; improvements in MDA, NO, and GSH with mean differences of 0.92, 6.16, and 24.37 µmol/L, respectively; and a significant improvement in FBS and hemoglobin A1c (HbA1c). Minor self-limiting gastrointestinal adverse events like bloating and constipation were associated with probiotics.

Conclusion: Probiotic supplementation can improve insulin resistance in patients with diabetes and ESRD undergoing regular hemodialysis. However, further research is needed to explore its effects on clinical outcomes.