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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
Participants in this group (n = 30) received metformin alone, administered in a daily dose of 1000 to 2000 mg divided into two doses, over a period of four weeks.
Participants (n = 30) received metformin (1000-2000 mg/day, divided in two doses) combined with a probiotic supplement (1 capsule three times daily) over a four-week period.
Participants in this group (n = 30) were treated with a combination of metformin (1000 - 2000 mg/day), a probiotic (1 capsule three times daily) and ursodeoxycholic acid (UDCA, 1 capsule (250mg) three times daily) for four weeks.
Public Health Institution Dom zdravlja Banja Luka
Banja Luka, Republika Srpska, Bosnia and Herzegovina
Change in fasting plasma glucose (FPG) from baseline to week 4
Fasting plasma glucose concentration will be measured in mmol/L to assess changes in glycemic control following treatment in each group.
Time frame: Baseline and after 4 weeks of intervention
Change in postprandial glucose (PPG) from baseline to week 4
Postprandial plasma glucose concentration will be measured 2 hours after a standardized meal to evaluate treatment efficacy. Unit of measure: mmol/L
Time frame: Baseline and after 4 weeks of intervention
Change in hemoglobin A1c (HbA1c) from baseline to week 4
Glycated hemoglobin (HbA1c) will be measured to assess average blood glucose levels over the preceding 4 weeks. Unit of measure: Percent (%)
Time frame: Baseline and after 4 weeks of intervention
Percentage of participants achieving HbA1c < 7.0% at week 4
Proportion of participants in each group achieving HbA1c values below 7.0%, indicating improved glycemic control. Unit of measure: Percentage of participants (%)
Time frame: After 4 weeks of intervention
Change in total cholesterol from baseline to week 4
Assessment of total serum cholesterol levels to evaluate lipid profile modulation in response to intervention. Unit of measure: mmol/L
Time frame: Baseline and after 4 weeks of intervention
Change in LDL cholesterol from baseline to week 4
Measurement of low-density lipoprotein cholesterol to assess cardiovascular risk changes. Unit of measure: mmol/L
Time frame: Baseline and after 4 weeks of intervention
Change in HDL cholesterol from baseline to week 4
Measurement of high-density lipoprotein cholesterol to evaluate potential improvement in lipid metabolism. Unit of measure: mmol/L
Time frame: Baseline and after 4 weeks of intervention
Change in triglycerides from baseline to week 4
Serum triglyceride levels will be measured to observe any changes due to intervention. Unit of measure: mmol/L
Time frame: Baseline and after 4 weeks of intervention
Change in C-Reactive Protein (CRP) from baseline to week 4
C-reactive protein will be quantified to assess the anti-inflammatory potential of the interventions. Unit of measure: mg/L
Time frame: Baseline and after 4 weeks of intervention
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