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Sponsored by: |
Aichi Gakuin University |
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Information provided by: | Aichi Gakuin University |
ClinicalTrials.gov Identifier: | NCT00858676 |
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 |
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Diabetes Mellitus Impaired Glucose Tolerance Coronary Artery Disease |
Drug: acarbose |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Multicenter Trial on Clinical Utility of Acarbose in Patients With Ischemic Heart Disease Accompanied by Abnormal Glucose Regulation |
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 |
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Acarbose: Experimental |
Drug: acarbose
50mg acarbose 3 times a day PO. duration: one year
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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.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Tatsuaki Matsubara, MD, PhD | +81-52-759-2111 | matt@dpc.aichi-gakuin.ac.jp |
Japan | |
Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University | |
Nagoya, Japan, 464-8650 |
Principal Investigator: | Tatsuaki Matsubara, MD, PhD | Department of Internal Medicine, School of Dentistry, Aichi Gakuin University |
Responsible Party: | Aichi Gakuin University ( Tatsuaki Matsubara, MD, PhD ) |
Study ID Numbers: | AGU-75 |
Study First Received: | March 9, 2009 |
Last Updated: | March 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00858676 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
acarbose diabetes mellitus impaired glucose tolerance coronary artery disease |
Arterial Occlusive Diseases Heart Diseases Metabolic Diseases Myocardial Ischemia Glucose Intolerance Diabetes Mellitus Vascular Diseases Endocrine System Diseases Ischemia |
Arteriosclerosis Coronary Disease Acarbose Hypoglycemic Agents Hyperglycemia Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Coronary Artery Disease |
Arterial Occlusive Diseases Heart Diseases Metabolic Diseases Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Physiological Effects of Drugs Glucose Intolerance Diabetes Mellitus Vascular Diseases Endocrine System Diseases |
Enzyme Inhibitors Arteriosclerosis Pharmacologic Actions Coronary Disease Acarbose Hypoglycemic Agents Hyperglycemia Cardiovascular Diseases Glucose Metabolism Disorders Coronary Artery Disease |