The EFFECTS OF 6-MONTH SUPPLEMENTATION OF PROBIOTICS IN ASSESSMENT OF ITS EFFECT ON THE METABOLIC PROFILE OF NATIVE NEPALESE WITH TYPE 2 DIABETES
Abstract
Objectives: Diabetes mellitus type 2 (T2DM) is a common metabolic disorder, marked by chronic hyperglycemia and insulin resistance that poses a major burden on global health. Recent studies associated gut microbiota dysbiosis with the development of T2DM and proposed probiotic supplementation as a therapeutic approach to restore microbial balance and reduce inflammation. The present study was aimed to examine the effect of probiotic supplementation on systemic inflammation and metabolic parameters in Nepalese patients with T2DM. Methods: An open-label, parallel-group controlled trial lasting 180 days enrolled 120 participants: 60 untreated diabetic individuals (baseline), and 60 diabetic patients receiving a multi-strain probiotic formulation (14 bacterial species, two capsules daily) and 100 completed the study and were analyzed. Clinical parameters were measured at baseline and at 180 days. Fasting blood samples were analyzed for glycemic parameters (fasting blood glucose, glycated hemoglobin [HbA1c], insulin, and C-peptide), lipid profiles, markers of inflammation (C-reactive protein [CRP], interleukin-6 [IL-6], tumor necrosis factor-alpha [TNF-α]), endotoxins, and adipokines. Results: Probiotic supplementation significantly improved glycemic control, with reduced fasting glucose (146.68±27.57 vs. 188.33±38.76 mg/ dL, p<0.05) and HbA1c (5.74±0.60% vs. 6.45±0.69%, p<0.05), along with elevated C-peptide and insulin (p<0.05). Lipid profiles demonstrated a substantial reduction in triglycerides (TG) and total cholesterol (p<0.01). Inflammatory markers decreased substantially: IL-6 (7.77±2.32 vs. 12.82±3.45 pg/mL, p<0.05), CRP (5.46±3.01 vs. 8.95±5.57 mg/L, p<0.01), and endotoxins (0.50±0.26 vs. 0.75±0.34 EU/mL, p<0.05). Analysis of variance confirmed significant differences among groups for these parameters (p<0.05). A post hoc power analysis revealed adequate power (≥0.88) for primary outcomes including fasting blood sugar, insulin, C-peptide, IL-6, TG, and total cholesterol, but low power for adipokines and TNF-α. Conclusion: One hundred and eighty days supplementation of probiotics significantly improved glycemic control, lipid metabolism, and inflammatory markers in Nepalese patients with T2DM, supporting probiotics as a valuable adjunct therapy in diabetes management.