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.