Coronary Artery Disease, Glucose Metabolism Disorders
Conditions
Keywords
Abnormal Glucose Tolerance, coronary artery disease, diabetes mellitus, clinical outcome
Brief summary
The purpose of this study is to determine whether the intervention for newly diagnosed abnormal glucose tolerance after coronary stenting will improve the long-term clinical outcome.
Detailed description
Recent studies have demonstrated that newly diagnosed abnormal glucose tolerance (AGT; diabetes mellitus and impaired glucose tolerance) are common among the patients with ischemic heart disease. Several large cohort studies indicate that people with prediabetic conditions, such as impaired glucose tolerance, have a raised risk of future cardiovascular disease. Intervention with acarbose can prevent myocardial infarction and cardiovascular disease in type 2 diabetic and IGT patients. However, the effect of acarbose to secondary prevention of myocardial infarction or cardiovascular events in patients with newly diagnosed AGT after coronary stenting remains unclear. The purpose of the present study is to determine whether the intervention to such abnormalities after coronary stenting will improve the long-term clinical outcome. This is a opened, randomized study to compare acarbose versus a standard lifestyle modification. Patients will have a 1:1 chance of receiving acarbose versus the standard lifestyle modification. There is some research evidence that suggests acarbose may improve clinical outcome in patients with type 2 diabetes and in IGT patients.
Interventions
DRUGAcarbose
Sponsors
Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan
Kobe City General Hospital
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Within 8 weeks since implantation of coronary artery stents for stable angina pectoris or acute coronary syndrome. * Abnormal glucose tolerance according to a 75 g oral glucose tolerance test (OGTT). * HbA1c is less than 6.5%. * Age is between 20 and 75 years (at time of consent). * Patients who can give informed consent themselves in writing.
Exclusion criteria
* Patients with abnormal glucose tolerance caused by other organic disorders such as pancreatitis, hemochromatosis, post pancreatectomy, hyperthyroidism, Cushing syndrome, Prader-Willi syndrome, etc. * Patients with planned angioplasty. * Patients with uncontrollable congestive heart failure. * Less than 6 months since last episode of cerebral infarction. * Patients who have received medication for diabetes mellitus before. * AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L. * Creatinine exceeding 2 mg/dl. * Patients with a history of ileus or less than 6 months since celiotomy. * Pregnant women or those who plan to become pregnant, or are in the lactation period. * Habitual drinker (more than 100 ml/day of alcohol). * Patients with a history of gastrectomy. * Patients for whom it is impossible to follow up for 5 years. * Any other reason that the clinical supervisors or clinical researchers may have for considering a case unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiovascular event free survival time | — |
Secondary
| Measure | Time frame |
|---|---|
| All causes of death | — |
| Occurrence of every cardiovascular event | — |
| Occurrence of in-stent restenosis | — |
| Conversion of abnormal glucose tolerance to type 2 diabetes | — |
| Change in homeostasis model assessment of insulin resistance | — |
| Change in hemoglobin A1c (HbA1c) | — |
| Change in lipid profile | — |
| Change in fasting, 2-hour blood glucose and insulin level | — |
Countries
Japan
Outcome results
None listed