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

Phase 4

• Conditions: Diabetes Mellitus; Impaired Glucose Tolerance; Coronary Artery Disease
• Interventions: Drug: acarbose

• Registration Number: NCT00858676
• Lead Sponsor: Aichi Gakuin University

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2009-03-09
• Study First Submitted QC: 2009-03-09
• Study First Posted: 2009-03-10
• Study Start: 2009-04
• Primary Completion: 2012-03
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-17
• Last Update Posted: 2012-07-18
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acarbose	acarbose	-

Primary Outcome Measures

Name	Time	Method
sudden cardiac death, fatal or non-fatal myocardial infarction, coronary revascularization, admission due to heart failure, fatal or non-fatal stroke	one year

Trial Locations

Locations (1)

Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University; 🇯🇵 Nagoya, Japan