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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Aichi Gakuin University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Tatsuaki Matsubara, MD, PhD, Aichi Gakuin University
ClinicalTrials.gov Identifier:
NCT00858676
First received: March 9, 2009
Last updated: July 17, 2012
Last verified: July 2012
  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 4

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:


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 2013
Primary Completion Date: March 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, professor, Aichi Gakuin University
ClinicalTrials.gov Identifier: NCT00858676     History of Changes
Other Study ID Numbers: AGU-75
Study First Received: March 9, 2009
Last Updated: July 17, 2012
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 September 22, 2014