check_circleStudy Completed
Diabetes mellitus
Bayer Identifier:
13928
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Influence of different approaches to dietary advising on the effects of acarbose treatment in obese diabetic patients under real-life setting
Trial purpose
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.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
423Trial Dates
May 2008 - March 2009Phase
N/ACould I Receive a placebo
NoProducts
Acarbose (Precose/Glucobay, BAYG5421)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Poland |
Primary Outcome
- Change in HbA1c value between initial and final visitdate_rangeTime Frame:approx. 3 mths after acarbose treatment initiationenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Number of participants with adverse events in both study groups. The influence of different approaches to dietary advising on the appearance of adverse events.date_rangeTime Frame:approx 3 mths after acarbose treatment initiationenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A