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
Conditions
Interventions
Product Name: Glucobay 50 / 100
Product Code: 9835.01.00
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Medizinische Klinik B, Herzzentrum Ludwigshafen
Eligibility
Sex/Gender
All
Inclusion criteria
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 (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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). ;Primary end point(s): Improvement in endothelial-dependen Vasodliation under Acarbose treatment > 50% compared to Placebo | — |
Countries
Germany
Outcome results
None listed