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

• Status: Unknown status
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

Inclusion Criteria:

• People with type 2 diabetes mellitus

• Age: 30-70 years

Exclusion Criteria:

• History of myocardial infarction, stroke within the previous 6 months

• Heart failure NYHA III or more

• Malignant disease

• Severe diabetes complications

• Severe hypo- or hypertension

• Chronic alcohol abuse

• Renal failure (creatinine >2mg/dl)