Type 2 Diabetes Mellitus
Conditions
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.
Interventions
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.
OTHERMetformin combined with probiotic (Normia® Jadran Galenski Laboratory) supplementation
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.
OTHERTriple therapy - metformin, probiotic and ursodeoxycholic acid (Bilexin®, Bosnalijek)
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.
Sponsors
University of Banja Luka
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in fasting plasma glucose (FPG) from baseline to week 4 | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in total cholesterol from baseline to week 4 | Baseline and after 4 weeks of intervention | Assessment of total serum cholesterol levels to evaluate lipid profile modulation in response to intervention. Unit of measure: mmol/L |
| Change in C-Reactive Protein (CRP) from baseline to week 4 | Baseline and after 4 weeks of intervention | C-reactive protein will be quantified to assess the anti-inflammatory potential of the interventions. Unit of measure: mg/L |
| Change in LDL cholesterol from baseline to week 4 | Baseline and after 4 weeks of intervention | Measurement of low-density lipoprotein cholesterol to assess cardiovascular risk changes. Unit of measure: mmol/L |
| Change in HDL cholesterol from baseline to week 4 | Baseline and after 4 weeks of intervention | Measurement of high-density lipoprotein cholesterol to evaluate potential improvement in lipid metabolism. Unit of measure: mmol/L |
| Change in triglycerides from baseline to week 4 | Baseline and after 4 weeks of intervention | Serum triglyceride levels will be measured to observe any changes due to intervention. Unit of measure: mmol/L |
Countries
Bosnia and Herzegovina
Outcome results
None listed