The Impact of Ursodeoxycholic Acid and Probiotics on Metabolic Outcomes in Type 2 Diabetic Patients Taking Metformin: a Randomized, Double-blind Clinical Trial
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Change in fasting plasma glucose (FPG) from baseline to week 4
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 25 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change in fasting plasma glucose (FPG) from baseline to week 4
Time Frame: Baseline and after 4 weeks of intervention
Fasting plasma glucose concentration will be measured in mmol/L to assess changes in glycemic control following treatment in each group.
Change in postprandial glucose (PPG) from baseline to week 4
Time Frame: Baseline and after 4 weeks of intervention
Postprandial plasma glucose concentration will be measured 2 hours after a standardized meal to evaluate treatment efficacy. Unit of measure: mmol/L
Change in hemoglobin A1c (HbA1c) from baseline to week 4
Time Frame: Baseline and after 4 weeks of intervention
Glycated hemoglobin (HbA1c) will be measured to assess average blood glucose levels over the preceding 4 weeks. Unit of measure: Percent (%)
Percentage of participants achieving HbA1c < 7.0% at week 4
Time Frame: After 4 weeks of intervention
Proportion of participants in each group achieving HbA1c values below 7.0%, indicating improved glycemic control. Unit of measure: Percentage of participants (%)
Secondary Outcomes
- Change in total cholesterol from baseline to week 4(Baseline and after 4 weeks of intervention)
- Change in LDL cholesterol from baseline to week 4(Baseline and after 4 weeks of intervention)
- Change in HDL cholesterol from baseline to week 4(Baseline and after 4 weeks of intervention)
- Change in triglycerides from baseline to week 4(Baseline and after 4 weeks of intervention)
- Change in C-Reactive Protein (CRP) from baseline to week 4(Baseline and after 4 weeks of intervention)