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

NCT00446810 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2007-09-27

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Benfotiamine

DRUG

Placebo

Sponsors & Collaborators

  • Ruhr University of Bochum

    lead OTHER

Principal Investigators

  • Diethelm Tschoepe, Prof.PhD. · Herz- und Diabeteszentrum NRW

  • Alin O Stirban, PhD · Herz- und Diabeteszentrum NRW

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Completion
2008-12-31

Countries

  • Germany

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00446810 on ClinicalTrials.gov