Influence of Different Approaches to Dietary Advising on the Effects of Acarbose Treatment in Obese Diabetic Patients Under Real-life Setting
CATERING
Compliance With Dietary Recommendations in Obese Diabetic Patients Undergoing Acarbose Therapy
2 other identifiers
observational
423
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2008
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 4, 2011
CompletedFirst Posted
Study publicly available on registry
April 12, 2011
CompletedMay 4, 2012
May 1, 2012
10 months
April 4, 2011
May 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c value between initial and final visit
approx. 3 mths after acarbose treatment initiation
Secondary Outcomes (1)
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
Study Arms (1)
Group 1
Interventions
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
Eligibility Criteria
Primary care clinic diabetic patients not treated with acarbose for approx. 3 mths.
You may qualify if:
- type 2 diabetes
- age\>18 years
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Unknown Facility
Many Locations, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 4, 2011
First Posted
April 12, 2011
Study Start
May 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
May 4, 2012
Record last verified: 2012-05