Effects of Benfotiamine and AGE on Endothelial Function in People With Diabetes (AGE-Benfo)
|Endothelial Dysfunction Type 2 Diabetes Mellitus||Drug: Benfotiamine 1050mg, 3 days Behavioral: high-AGE vs. low-AGE meal||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind
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|
- A high-AGE meal causes a more pronounced postprandial endothelial dysfunction comparing to a low-AGE meal in people with type 2 diabetes mellitus.
- 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.
- To investigate whether treatment with Benfotiamine 1050mg/day for 3 days has a protective effect on endothelial function after a high-AGE meal
|Study Start Date:||November 2004|
|Estimated Study Completion Date:||January 2006|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437008
|Heart and Diabetes Center NRW|
|Bad Oeynhausen, Germany, 32545|
|Principal Investigator:||Alin O Stirban, Dr||Heart and Diabetes Center NRW|