The Impact of Ursodeoxycholic Acid and Probiotics on Metabolic Outcomes in Type 2 Diabetic Patients Taking Metformin

The Impact of Ursodeoxycholic Acid and Probiotics on Metabolic Outcomes in Type 2 Diabetic Patients Taking Metformin: a Randomized, Double-blind Clinical Trial

A monocentric prospective randomized double-blind controlled study included 90 patients with T2DM on metformin therapy. Patients were randomized into three groups: a metformin group (1000 to 2000 mg daily in two doses), a metformin and probiotic group (metformin + oral probiotic 3x1 capsule), and a metformin, probiotic and UDCA group (metformin + probiotic 3x1 caps + UDCA 3x1 capsule) for four weeks. Two visits were conducted during the study - at the beginning and the end. Visits involved patient interviews, clinical data collection, anthropometric measurements, biochemical analyses and stool sample analysis for the presence of probiotic culture and UDCA.

Inclusion Criteria:

• Age ≥ 25 years
• Clinical diagnosis of type 2 diabetes mellitus (T2DM) within the past 12 months
• Body mass index (BMI) ≥ 25 kg/m²
• Stable metformin therapy (1000-2000 mg daily in divided doses)
• No use of probiotics, antibiotics, vitamins, or minerals in the past 30 days

Exclusion Criteria:

• Diagnosis of type 1 diabetes mellitus
• History or diagnosis of gastrointestinal diseases
• Chronic kidney disease
• Valvular heart disease
• Pregnancy
• Presence of any acute infection