Influence of Different Approaches to Dietary Advising on the Effects of Acarbose Treatment in Obese Diabetic Patients Under Real-life Setting

Study Overview
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Brief Summary
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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.

Official Title
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Compliance With Dietary Recommendations in Obese Diabetic Patients Undergoing Acarbose Therapy

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Glucobay (Acarbose, BAYG5421)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 2 diabetes age>18 years Exclusion Criteria: Hypersensitivity to acarbose or any of the excipients age<18 pregnancy and in nursing inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction chronic intestinal diseases associated with marked disorders of digestion or absorption states which may deteriorate as a result of increased gas formation in the intestine, (e.g. Roemheld's syndrome [an angina pectoris-like syndrome or aggravation of an angina pectoris due to the post-prandial filling of the stomach] and larger hernias) hepatic and severe renal impairment (creatinine clearance <25 mL/min/ 1,73m2)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Glucobay (Acarbose, BAYG5421)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c value between initial and final visit |  | approx. 3 mths after acarbose treatment initiation | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Acarbose, Diet, Compliance, Advising