Effect of probiotics derivatives (postbiotics and metabiotics) on glycemic control in individuals with type 2 diabetes: a randomized clinical trial (DELI_Diab study)

Introduction: Probiotics have demonstrated positive effects on obesity and type 2 diabetes (T2D) in various studies. Postbiotics, specifically nonliving bacterial lysates derived from cell walls and DNA, are increasingly recognized as safe, stable, and effective alternatives for improving host metabolic health. Aim: DV - NRRL B-68023 as an adjunct to standard antidiabetic therapy. Material and methods: lysate twice daily or a matching placebo. Blinding was ensured through identical masked packaging. The primary efficacy analysis was performed on a per-protocol (PP) population of 42 participants (intervention, n=20; placebo, n=22) who completed the 3-month treatment and 3-month follow-up. Primary endpoints were HbA1c and fasting plasma glucose (FPG). Secondary endpoints included HOMA-2 modeled insulin sensitivity (%S), β-cell function (%B), and anthropometric parameters, evaluated at baseline, 3, and 6 months. The trial was registered at ClinicalTrials.gov (NCT05770076). Results: The primary analysis revealed a significant overall treatment effect for HbA1c (p