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

Ruhr University of Bochum

Status and phase

Completed

Phase 4

Conditions

Endothelial Dysfunction

Type 2 Diabetes Mellitus

Treatments

Behavioral: high-AGE vs. low-AGE meal

Drug: Benfotiamine 1050mg, 3 days

Study type

Interventional

Funder types

Other

Identifiers

NCT00437008

Benfo-1-2005

Details and patient eligibility

About

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.

Full 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).

Sex

All

Ages

35 to 70 years old

Volunteers

No Healthy Volunteers

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