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Clinical Trials/NCT07072949
NCT07072949CompletedPhase 1

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

University of Banja Luka2 sites in 1 country90 target enrollmentStarted: January 3, 2023Last updated:
Conditions

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)

Investigators

Sponsor
University of Banja Luka
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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