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
NCT ID: NCT07072949 Phase: PHASE1 Status: COMPLETED Enrollment: 90 Completion: 2024-01-31
Conditions
Type 2 Diabetes Mellitus
Interventions
Metformin Monotherapy, Metformin combined with probiotic (Normia® Jadran Galenski Laboratory) supplementation, Triple therapy - metformin, probiotic and ursodeoxycholic acid (Bilexin®, Bosnalijek)
Summary
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.
Primary Outcome
Change in fasting plasma glucose (FPG) from baseline to week 4