Effects of Benfotiamine and AGE on Endothelial Function in People With Diabetes (AGE-Benfo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00437008
Recruitment Status : Completed
First Posted : February 19, 2007
Last Update Posted : February 19, 2007
Information provided by:
Ruhr University of Bochum

Brief 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.

Condition or disease Intervention/treatment Phase
Endothelial Dysfunction Type 2 Diabetes Mellitus Drug: Benfotiamine 1050mg, 3 days Behavioral: high-AGE vs. low-AGE meal Phase 4

Detailed Description:

AGEs are a heterogeneous group of compounds formed by the nonenzymatic reaction of reducing sugars with proteins, lipids and nucleic acids. Diet has been recognized as an important exogenous source of AGEs. There is evidence for the implication of AGEs in the pathogenesis of diabetes-related complications, atherosclerosis, ageing processes or Alzheimer´s disease. Although, only little information exists about their effects in humans. The hypotheses of this study are that a high-AGE meal leads to a more important acute vascular dysfunction comparing to a low-AGE meal, and that a 1050mg/day Benfotiamine therapy for 3 days has a protective effect on the endothelial function.

Twenty-one people with type 2 diabetes shall be investigated in a randomized, single-blinded (investigator), cross-over design (please compare design description).

Study Type : Interventional  (Clinical Trial)
Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Acute Effects of a Low-AGE vs. High-AGE Meal on Postprandial Endothelial Function in People With Type 2 Diabetes Mellitus. Protective Effects of Benfotiamine
Study Start Date : November 2004
Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. A high-AGE meal causes a more pronounced postprandial endothelial dysfunction comparing to a low-AGE meal in people with type 2 diabetes mellitus.

Secondary Outcome Measures :
  1. The influence of high-AGE vs. low-AGE meal on the laboratory parameters that mirror AGE-metabolism, oxidative stress, endothelial dysfunction and inflammation shall be investigated.
  2. To investigate whether treatment with Benfotiamine 1050mg/day for 3 days has a protective effect on endothelial function after a high-AGE meal

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00437008

Heart and Diabetes Center NRW
Bad Oeynhausen, Germany, 32545
Sponsors and Collaborators
Ruhr University of Bochum
Principal Investigator: Alin O Stirban, Dr Heart and Diabetes Center NRW Identifier: NCT00437008     History of Changes
Other Study ID Numbers: Benfo-1-2005
First Posted: February 19, 2007    Key Record Dates
Last Update Posted: February 19, 2007
Last Verified: February 2007

Keywords provided by Ruhr University of Bochum:
endothelial dysfunction
flow-mediated dilatation
advanced glycation end products

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action