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

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ClinicalTrials.gov Identifier: NCT01167231
Recruitment Status : Completed
First Posted : July 22, 2010
Last Update Posted : August 25, 2010
Sponsor:
Information provided by:
Bayer

Brief Summary:
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.

Condition or disease Intervention/treatment
Diabetes Mellitus Drug: Acarbose (Glucobay, BAYG5421)

Study Type : Observational
Actual Enrollment : 3310 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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.
Study Start Date : May 2007
Primary Completion Date : March 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia
Drug Information available for: Acarbose
U.S. FDA Resources

Group/Cohort Intervention/treatment
Group 1 Drug: Acarbose (Glucobay, BAYG5421)
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 Outcome Measures :
  1. 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 Outcome Measures :
  1. Effect of acarbose on HbA1c, fasting and postprandial glycemia and on lipid profile [ Time Frame: approximately 6 months after acarbose treatment initiation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic diabetic patients not treated with acarbose for at least 3 months.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01167231


Locations
Poland
Many Locations, Poland
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Medical Director, Bayer Sp. z o.o.
ClinicalTrials.gov Identifier: NCT01167231     History of Changes
Other Study ID Numbers: 13066
GB0710PL
First Posted: July 22, 2010    Key Record Dates
Last Update Posted: August 25, 2010
Last Verified: August 2010

Keywords provided by Bayer:
Diabetes
Acarbose

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Acarbose
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs