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

NCT ID: NCT00858676

Last Updated: 2012-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2013-03-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus Impaired Glucose Tolerance Coronary Artery Disease

Keywords

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acarbose diabetes mellitus impaired glucose tolerance coronary artery disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acarbose

Group Type ACTIVE_COMPARATOR

acarbose

Intervention Type DRUG

50mg acarbose 3 times a day PO. duration: one year

Interventions

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acarbose

50mg acarbose 3 times a day PO. duration: one year

Intervention Type DRUG

Other Intervention Names

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Glucobay

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aichi Gakuin University

OTHER

Sponsor Role lead

Responsible Party

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Tatsuaki Matsubara, MD, PhD

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tatsuaki Matsubara, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University

Nagoya, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Tatsuaki Matsubara, MD, PhD

Role: CONTACT

Phone: +81-52-759-2111

Email: [email protected]

Facility Contacts

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Tatsuaki Matsubara, MD, PhD

Role: primary

Other Identifiers

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AGU-75

Identifier Type: -

Identifier Source: org_study_id