drugset / Trial / NCT00446810

Chronic Treatment With Benfotiamine Restores Endothelial Function in People With Type 2 Diabetes Mellitus

NCT00446810 ↗

Phase 4 Unknown 30 enrolled Ruhr University of Bochum
RandomizedCrossoverDouble-blindPrevention

Summary

An AGE-rich diet can induce after 2-6 weeks persistent increases in mediators linked to vascular dysfunction (e.g. TNFα, VCAM-1) in people with type 2 diabetes mellitus (T2DM). Benfotiamine (BT), the liposoluble derivative of vitamin B1, blocks several pathways common to hyperglycaemia- and AGE-induced endothelial dysfunction. We have shown that advanced glycation end products (AGE) of a regular mixed meal can acutely induce vascular dysfunction in T2DM and that this effects can be prevented by a three days pretreatment with BT. The hypotheses of this study are that chronical treatment with benfotiamine (900 mg/day for 6 weeks) in people with type 2 diabetes mellitus: 1. prevents postprandial impairment of endothelial function after a high-AGE meal. 2. Improves fasting endothelial function. 3. Improves parameters of autonomic function in fasting and postprandial state. 4. Improves insulin sensitivity and prevents postprandial increase in insulin resistance.

Timeline

Start
2007-09
Primary completion
—
Completion
2008-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Benfotiamine Small molecule 900 mg —