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| ID | Type | Description | Link |
|---|---|---|---|
| GB0810PL | Other Identifier | Company internal |
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It has been recently suggested, that not the diet by itself, but also patient's adherence to dietary recommendations and all actions performed to improve dietary compliance, may be a significant factor influencing blood glucose control. There are no clinical data on the influence of different approaches to dietary advising on the effects of acarbose treatment in obese diabetic patients under real-life setting in Poland. Thus, the aim of this study was to assess the influence of different approaches to dietary advisory on the effects of acarbose treatment (reflected by changes in HbA1c) in obese DM patients. We also intended to assess the influence of different approaches to dietary advising on the appearance of potential adverse events in acarbose treated obese DM patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucobay (Acarbose, BAYG5421) | Drug | Patients treated with acarbose tablets under the real-life setting. Dosing regimen customised to the needs of each participating patient according to the investigators assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c value between initial and final visit | approx. 3 mths after acarbose treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events in both study groups. The influence of different approaches to dietary advising on the appearance of adverse events. | approx 3 mths after acarbose treatment initiation |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care clinic diabetic patients not treated with acarbose for approx. 3 mths.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Poland |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D020909 | Acarbose |
| ID | Term |
|---|---|
| D014312 | Trisaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |