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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Metformin Group | Other |
| |
| The Metformin/Probiotic Group | Other |
| |
| The Metformin/Probiotic/UDCA Group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin Monotherapy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 (%) | 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 (%) | After 4 weeks of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and after 4 weeks of intervention |
| Change in LDL cholesterol from baseline to week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Public Health Institution Dom zdravlja Banja Luka | Banja Luka | Republika Srpska | 78000 | Bosnia and Herzegovina |
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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.
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| Metformin combined with probiotic (Normia® Jadran Galenski Laboratory) supplementation | Other | 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. |
|
| Triple therapy - metformin, probiotic and ursodeoxycholic acid (Bilexin®, Bosnalijek) | Other | 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. |
|
Measurement of low-density lipoprotein cholesterol to assess cardiovascular risk changes. Unit of measure: mmol/L |
| 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 | 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 | 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 | Baseline and after 4 weeks of intervention |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| D019587 | Dietary Supplements |
| D014580 | Ursodeoxycholic Acid |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |
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