NCT00446810

Brief 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. 1.prevents postprandial impairment of endothelial function after a high-AGE meal.
  2. 2.Improves fasting endothelial function.
  3. 3.Improves parameters of autonomic function in fasting and postprandial state.
  4. 4.Improves insulin sensitivity and prevents postprandial increase in insulin resistance.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

September 27, 2007

Status Verified

September 1, 2007

First QC Date

March 12, 2007

Last Update Submit

September 25, 2007

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetesendothelial dysfunctionbenfotiaminepostprandialautonomic neuropathyadvanced glycation end products

Outcome Measures

Primary Outcomes (1)

  • Endothelial function (flow mediated dilatation - ultrasound- and reactive hyperemia- laser doppler-)

    September 2007- December 2008

Secondary Outcomes (1)

  • Parameters of autonomic neuropathy

    September 2007- December 2008

Study Arms (2)

A1

ACTIVE COMPARATOR

Benfotiamine

Drug: Benfotiamine

A2

ACTIVE COMPARATOR
Drug: Placebo

Interventions

BenfotiamineDRUG
A1
PlaceboDRUG
A2

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People with type 2 diabetes mellitus
  • Age: 30-70 years

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herz- und Diabeteszentrum NRW, Georgstr. 11

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

RECRUITING

Related Publications (1)

  • Stirban A, Negrean M, Stratmann B, Gawlowski T, Horstmann T, Gotting C, Kleesiek K, Mueller-Roesel M, Koschinsky T, Uribarri J, Vlassara H, Tschoepe D. Benfotiamine prevents macro- and microvascular endothelial dysfunction and oxidative stress following a meal rich in advanced glycation end products in individuals with type 2 diabetes. Diabetes Care. 2006 Sep;29(9):2064-71. doi: 10.2337/dc06-0531.

    PMID: 16936154BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

benphothiamine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Diethelm Tschoepe, Prof.PhD.

    Herz- und Diabeteszentrum NRW

    STUDY DIRECTOR

  • Alin O Stirban, PhD

    Herz- und Diabeteszentrum NRW

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alin O Stirban, PhD

CONTACT

0049573197astirban@hdz-nrw.de

Diethelm Tschoepe, Prof. PhD

CONTACT

0049573197dtschoepe@hdz-nrw.de

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 12, 2007

First Posted

March 13, 2007

Study Start

September 1, 2007

Study Completion

December 1, 2008

Last Updated

September 27, 2007

Record last verified: 2007-09

Locations

DE(1)