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

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.

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Key information

Conditions

Diabetes Mellitus Behavior Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Metabolic Diseases Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Glucobay (Acarbose, BAYG5421)

Drug

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

Primary outcomes

Change in HbA1c value between initial and final visit

Time frame: approx. 3 mths after acarbose treatment initiation

Secondary outcomes

Number of participants with adverse events in both study groups. The influence of different approaches to dietary advising on the appearance of adverse events.

Time frame: approx 3 mths after acarbose treatment initiation

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Compliance With Dietary Recommendations in Obese Diabetic Patients Undergoing Acarbose Therapy

Acronym: CATERING

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Apr 12, 2011
Registry last updated: May 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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