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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.
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benfotiamine 1050mg, 3 days | Drug | |||
| high-AGE vs. low-AGE meal | Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| A high-AGE meal causes a more pronounced postprandial endothelial dysfunction comparing to a low-AGE meal in people with type 2 diabetes mellitus. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alin O Stirban, Dr | Heart and Diabetes Center NRW | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart and Diabetes Center NRW | Bad Oeynhausen | 32545 | Germany |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C013835 | benphothiamine |
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| D004700 | Endocrine System Diseases |