Coronary Artery Disease, Diabetes Mellitus, Impaired Glucose Tolerance
Conditions
Keywords
acarbose, diabetes mellitus, impaired glucose tolerance, coronary artery disease
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.
Interventions
DRUGacarbose
50mg acarbose 3 times a day PO. duration: one year
Sponsors
Aichi Gakuin University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sudden cardiac death, fatal or non-fatal myocardial infarction, coronary revascularization, admission due to heart failure, fatal or non-fatal stroke | one year |
Countries
Japan
Contacts
Primary ContactTatsuaki Matsubara, MD, PhD
Outcome results
None listed