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| Name | Class |
|---|---|
| Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan | OTHER |
| Kobe City General Hospital | OTHER |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acarbose | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular event free survival time |
| Measure | Description | Time Frame |
|---|---|---|
| Conversion of abnormal glucose tolerance to type 2 diabetes | ||
| All causes of death | ||
| Occurrence of every cardiovascular event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Koichi Tamita, MD. | Division of Cardiology, Kobe General Hospital | Principal Investigator |
| Minako Katayama, MD | Division of Clinical Research Promotion, Institute of Biomedical Research and Innovation. | Study Director |
| Yutaka Furukawa, MD | Division of Cardiology, Kobe General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Biomedical Research and Innovation. | Kobe | Hyogo Pref. | 650-0047 | Japan | ||
| Kobe City General Hospital/Institute of Biomedical Research and Innovation |
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| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D003324 | Coronary Artery Disease |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
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| ID | Term |
|---|---|
| D020909 | Acarbose |
| ID | Term |
|---|---|
| D014312 | Trisaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Occurrence of in-stent restenosis |
| Change in fasting, 2-hour blood glucose and insulin level |
| Change in homeostasis model assessment of insulin resistance |
| Change in hemoglobin A1c (HbA1c) |
| Change in lipid profile |
| Kobe |
| Hyogo Pref. |
| 650-0047 |
| Japan |
| Kawasaki Medical School Hospital | Kurashiki | Okayama-ken | 701-0192 | Japan |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D004700 | Endocrine System Diseases |