Effects of UDCA and probiotics on metabolic outcomes in type 2 diabetes patients on metformin: A randomized trial in Bosnia and Herzegovina
Abstract
BackgroundRecent research highlights the pivotal role of gut microbiota and bile acids as modulators of metabolic homeostasis in type 2 diabetes (T2D). The concomitant use of probiotics and ursodeoxycholic acid (UDCA) may potentiate glycemic and lipid control via complementary mechanisms.ObjectiveTo evaluate the metabolic effects of probiotic supplementation and its combination with UDCA in metformin-treated T2D patients.MethodsIn this monocentric, prospective, randomized, double-blind, controlled trial, 90 patients with T2D on metformin therapy were randomized into three groups: metformin-only (MG), metformin plus probiotic (MPG), and metformin plus probiotic plus UDCA (MPUG). The intervention lasted 4 weeks. Primary outcomes included changes in fasting glucose, postprandial glucose and HbA1c. Secondary outcomes included lipid profile, C-reactive protein (CRP), and fecal levels of probiotics and UDCA. Two visits were conducted during the study - at the beginning and at the end. Visits involved patient interviews, clinical data collection, anthropometric measurements, blood biochemical analyses, and stool sample analysis for the presence of probiotic culture and UDCA concentrations.ResultsAfter 4 weeks, the MPUG group showed a significant reduction in fasting glucose (-1.7 mmol/L; 95% CI: -2.2 to -1.2), postprandial glucose (-1.3 mmol/L; 95% CI: -1.8 to -0.7), and HbA1c (-0.49%; 95% CI: -0.66 to -0.31) compared to the MG group. Total cholesterol and LDL cholesterol were also…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 90 participants or records.
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