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The goal of this clinical trial is to to study the effect of Optifiber PHGG on carbohydrate metabolism in patients with type 2 diabetes mellitus. The main questions it aims to answer are:
The observational study is planned to include approximately 80 patients diagnosed with type 2 diabetes mellitus, with 40 patients divided into the main and control groups. In the control group, the necessary information will be collected retrospectively using archived patient data. In the main (study) group, data will be collected prospectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OptiFibre | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nestle Optifibre | Dietary Supplement | The main (study) group will include patients who are additionally prescribed dietary fiber supplements Optifiber (regimen of use from 1 to 3 days - 1 sachet per day (5 g) - lunch, from 4 to 6 days - 2 sachets per day (10 g) - lunch + dinner, from 7 to 90 ± 2 days - 3 sachets per day (15 g)) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c in OptiFibre group in comparison to HbA1c control group in 3 months | 84 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State clinical hospital named after V.P. Demikhov | Moscow | Russia |
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|
| 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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