Effects of Benfotiamine and AGE on Endothelial Function in People With Diabetes

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine whether there are differences in postprandial endothelial function following a high-AGE(Advanced Glycation End-products) meal vs. a low-AGE meal. We also intend to investigate if the therapy with 1050mg Benfotiamine for 3 days protects against the postulated deterioration of endothelial function after a high-AGE meal in people with type 2 diabetes mellitus.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruhr University of Bochum
• Treatments: Benphothiamine

Criteria

Inclusion Criteria:

• type 2 diabetes mellitus

• age: 35-70 years

Exclusion Criteria:

• Heart failure corresponding to NYHA- class III and IV

• history of stroke

• history of myocardial infarction

• unstable angina pectoris

• peripheral artery disease stadium IIb and more

• kidney disease (Creatinine > 1,8 mg/dl and/or creatinine clearance <50 ml/min calculated according to the Cockroft formula and/or macroalbuminuria >200 mg/l)

• malignant diseases

• chronical alcohol consumption (more than 50 ml of highly concentrated alcohol or equivalents / day)

• pregnancy or lactation

• potentially child- bearing women without sufficient contraception (sufficient contraception is defined as the use of a contraceptive method that has an efficiency of over 99% (according to CHMP/EWP/225/02)). A pregnancy test will be performed before the commencement of the study.

• arterial hypotonia (blood pressure<90/50 mmHg) or arterial hypertonia with systolic blood pressure >159 mmHg and/or diastolic blood pressure >99 mmHg

• arterial hypertonia requiring more than three antihypertensive agents

• advanced diabetes complications (subjects must have been investigated with regard to these complications maximum 6 months previously by a specialized physician) such as:

• proliferative diabetic retinopathy

• diabetic neuropathy requiring morphium derivatives

• patients with an acute foot syndrome

• HbA1c >10 %

• participation to other studies within the previous 3 months