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.|
|ClinicalTrials.gov Identifier: NCT00437008|
Recruitment Status : Completed
First Posted : February 19, 2007
Last Update Posted : February 19, 2007
|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|
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|
|Intervention Model:||Crossover Assignment|
|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|
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT00437008
|Heart and Diabetes Center NRW|
|Bad Oeynhausen, Germany, 32545|
|Principal Investigator:||Alin O Stirban, Dr||Heart and Diabetes Center NRW|