Trial Condition(s):
Diabetes Mellitus
Influence of different approaches to dietary advising on the effects of acarbose treatment in obese diabetic patients under real-life setting (CATERING)
Bayer Identifier:
13928
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Poland | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Compliance with dietary recommendations in obese diabetic patients undergoing acarbose therapy
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Change in HbA1c value between initial and final visitTimeframe: approx. 3 mths after acarbose treatment initiation
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.Timeframe: approx 3 mths after acarbose treatment initiation
Additional Information
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