Impact of Acarbose on Abnormal Glucose Regulation in Patients With Coronary Artery Disease (AAA Trial) - Full Text View

Sponsor:	Aichi Gakuin University
Information provided by:	Aichi Gakuin University
ClinicalTrials.gov Identifier:	NCT00858676

Purpose

The objective of this trial is to investigate the effect of early treatment of glucose toxicity with acarbose, a drug to control postprandial hyperglycemia, on the occurence of cardiovascular events and the inhibition of atherosclerosis.

Condition	Intervention	Phase
Diabetes Mellitus Impaired Glucose Tolerance Coronary Artery Disease	Drug: acarbose	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Multicenter Trial on Clinical Utility of Acarbose in Patients With Ischemic Heart Disease Accompanied by Abnormal Glucose Regulation

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

Drug Information available for: Dextrose Acarbose

U.S. FDA Resources

Further study details as provided by Aichi Gakuin University:

Primary Outcome Measures:

sudden cardiac death, fatal or non-fatal myocardial infarction, coronary revascularization, admission due to heart failure, fatal or non-fatal stroke [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	April 2009
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Acarbose	Drug: acarbose 50mg acarbose 3 times a day PO. duration: one year Other Name: Glucobay

Detailed Description:

Acarbose suppresses the postprandial increase in plasma glucose levels by inhibiting the activities of alpha-amylase and alpha-glucosidase involved in digestion and absorption of carbohydrates in the intestine. A clinical study involving patients with type 2 diabetes demonstrated that acarbose decreased the post-load glucose level and improved glycosylated hemoglobin control. A prospective study involving patients with impaired glucose tolerance (IGT) demonstrated that acarbose inhibited progression to type 2 diabetes and significantly reduced the risk of cardiovascular diseases. It has also been reported that acarbose slows increase in the intima-media thickness and inhibits the progression of atherosclerosis. A significant proportion of patients with acute coronary syndrome and those with stable angina pectoris suffer from diabetes or IGT, and their prognosis is poor.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who have been diagnosed with coronary artery disease, with type 2 diabetes or impaired glucose tolerance

Exclusion Criteria:

Patients scheduled to undergo revascularization at the time of enrollment
Patients who are being treated with an oral hypoglycemic drug or an insulin preparation
Patients with a history of laparotomy of ileus
Pre- and postoperative patients or individuals with severe infection or serious trauma
Patients with gastrointestinal disorders such as diarrhea and vomiting
Patients with a history of hypersensitivity to acarbose
Pregnant or possibly pregnant women
Patients who are judged by the attending physician to be otherwise ineligible

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858676

Contacts

Contact: Tatsuaki Matsubara, MD, PhD

+81-52-759-2111

matt@dpc.aichi-gakuin.ac.jp

Locations

Japan
Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University	Recruiting
Nagoya, Japan, 464-8650
Contact: Tatsuaki Matsubara, MD, PhD +81-52-759-2111
Principal Investigator: Tatsuaki Matsubara, MD, PhD

Sponsors and Collaborators

Aichi Gakuin University

Investigators

Principal Investigator:

Tatsuaki Matsubara, MD, PhD

Department of Internal Medicine, School of Dentistry, Aichi Gakuin University

More Information

No publications provided

Responsible Party:	Tatsuaki Matsubara, MD, PhD, Aichi Gakuin University
ClinicalTrials.gov Identifier:	NCT00858676 History of Changes
Other Study ID Numbers:	AGU-75
Study First Received:	March 9, 2009
Last Updated:	June 22, 2010
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Aichi Gakuin University:

acarbose
diabetes mellitus
impaired glucose tolerance
coronary artery disease

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Glucose Intolerance
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Acarbose
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012