Impact of Acarbose Therapy in Abnormal Glucose Tolerance Patients with Coronary Artery Disease

UMIN ID: UMIN000000544

Registered date:01/07/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: coronary artery disease with diabetes, including impaired glucose tolerance
• Date of first enrollment: 2006/11/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Acarbose is initiated before each meal with 50mg/time, 3 times/day, and increased to 100mg/time after examining tolerability if there is no enough therapeutic effect. However, the dosage shall be determined by their personal doctors.
Diet and exercise

Outcome(s)

• Primary Outcome: incidence of cardiovascular events: new onset myocardial infarction, worsening anginal status and/or angiographic restenosis Carotid intima-medial thickness(IMT)
• Secondary Outcome: 1-1)Ultrasonic echo cardiography(IVS; Interventricular Septal Thickness, EF; Ejection Fraction, E/A, LVDd; Left Ventricular Diastolic dimension) 2-1)HbA1c 2-2)IRI 2-3)blood glucose levels 2-4)HOMA-R,HOMA-beta 3)Plasma lipid profile

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: Any subject who applies to the article below shall be excluded. 1) Patients on oral antidiabetic or insulin preparation 2) Patients with a history of ileus or undergone laparotomy 3) Patients with severe liver dysfunction or renal dysfunction 4) Patients with serious case of ketosis or diabetical coma, or precoma 5) Patients with severe infection disease, or in the perioperative period, or with extreme trauma 6) Patients with gastrointestinal problems such as diarrhea, vomiting 7) Patients with a history of sensitivity to Acarbose 8) Pregnant or possibly pregnant women 9) Patients judged by the investigator/subinvestigator to be ineligible for some other reason

Related Information

• Primary Sponsor: Cardiovascular Center,Anjo Kosei Hospital
• Source(s) of Monetary Support: self funding