Prevention of Postprandial Hyperglycemia by Acarbose May be a Promising Therapeutic Strategy for Reducing the Increased Risk for Cardiovascular Disease

The use of acarbose in impaired glucose tolerance (IGT) and type 2 diabetic subjects has been associated with a significant reduction of cardiovascular events. Additionally, acarbose has been shown to have a beneficial influence on some of the other cardiovascular risk factors (metabolic syndrome components). Thus, prevention of postprandial hyperglycemia by acarbose may be a promising therapeutic strategy for reducing the increased risk for cardiovascular disease. Further studies are needed to confirm the influence of acarbose on cardiovascular risk factors in the real life setting.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

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

Diabetes Mellitus
Age >/= 18 years
Naive to acarbose (minimum 3 months before inclusion)

Exclusion criteria

Hypersensitivity to acarbose or any of the excipients
Age <18 years
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 postprandial filling of the stomach] and larger hernias)
Hepatic and severe renal impairment (creatinine clearance <25 mL/min/ 1,73m2)

Treatment and study plan

Acarbose (Glucobay, 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

Safety, tolerability of acarbose and its effect on body weight, waist circumference and blood pressure

Time frame: approximately 6 months after acarbose treatment initiation

Secondary outcomes

Effect of acarbose on HbA1c, fasting and postprandial glycemia and on lipid profile

Time frame: approximately 6 months after acarbose treatment initiation

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Acarbose in Cardiovascular Risk Management. Assessment of Clinical Efficacy and Safety of Acarbose and Its Effect on Selected Cardiovascular Risk Factors in Type 2 Diabetes Patients.

Acronym: ABDOMEN

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Jul 22, 2010
Registry last updated: Aug 25, 2010

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.

Published trials that share one or more normalized conditions with this study.

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