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

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Glucobay (Acarbose, BAYG5421)

• Registration Number: NCT01333774
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2011-04-04
• Study First Submitted QC: 2011-04-11
• Study First Posted: 2011-04-12
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-03
• Last Update Posted: 2012-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 423

Inclusion Criteria

• type 2 diabetes
• age>18 years

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Glucobay (Acarbose, BAYG5421)	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c value between initial and final visit	approx. 3 mths after acarbose treatment initiation

Secondary Outcome Measures

Name	Time	Method
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