A double-blind, randomised placebo controlled study of the effects of Acarbose on endothelial function, hemostatic and fibrinolytic plasmatic factors in patients with stable coronary artery disease and either impaired glucose intolerance or newly diagnosed diabetes mellitus

Conditions: 1. To study the effect of Acarbose treatment on endothelial function as a potential mechanism for the beneficial effects of better postprandial glycemic control in patients with impaired glucose tolerance or newly diagnosed diabetes mellitus

Registration Number: EUCTR2004-002579-17-DE

Lead Sponsor: Medizinische Klinik B, Herzzentrum Ludwigshafen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Male and female subjects aged between 40 and 75 years with IGT/new diagnosed diabetes, with body mass index between 25 and 40 kg/m2
2. Patients with stable angina pectoris (<=CCS II) and angiographically documented coronary artery disease not requiring immediate revascularization
3. Informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Current smokers
- Participation in an other clinical study during the previous 1,5 months
- Evidence of significant hepatic, renal, cardiac or pulmonary insufficiency
- History of malignant neoplasms (treated within the last 1 year) other than basal cell
carcinoma of the skin.
- Other serious diseases, which might influence the clinical course
- Recent major surgery or childbirth
- Pregnancy or lactation
- History of malabsorption
- regular intake of narcotics
- regular intake of more than 30 g alcohol for female or 40 g alcohol for male
- a clear deviation from the norm at the clinical findings, which, in the opinion of the Investigator, would preclude unequivocal interpretation of the findings.
- Contraindication to Acarbose or previous interrupted Acarbose treatment due to serious side effects.
- Type I diabetes
-Pre-treatment with alpha-glucosidase inhibitors, metformin or other drugs, influencing insulin resistance.
- Pre-treatment of ACE-inhibitors and statins because of their influence on endothelial function.
- poor metabolic control (HBA1c>8), plasma glucose level up to 300 mg/dL postprandial

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. To study the effect of Acarbose treatment on endothelial function as a potential mechanism for the beneficial effects of better postprandial glycemic control.<br>;Secondary Objective: 2. To study the effect of Acarbose treatment on marker of the coagulation, fibrinolytic, and platelet function (vWF, pSelectin, FVII, fibrinogen, PAI-1; 8-Iso PGF2alpha).<br>;Primary end point(s): Improvement in endothelial-dependen Vasodliation under Acarbose treatment > 50% compared to Placebo<br><br>

Secondary Outcome Measures