Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00437008
Status:
COMPLETED
Last Update Posted:
2007-02-19
First Post:
2007-02-15
Brief Title:
Effects of Benfotiamine and AGE on Endothelial Function in People With Diabetes
Sponsor:
Ruhr University of Bochum
Organization:
Ruhr University of Bochum
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AGE-Benfo
Brief Summary:
The purpose of the study is to determine whether there are differences in postprandial endothelial function following a high-AGEAdvanced 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
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 Alzheimers 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 1050mgday 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
Twenty-one people with type 2 diabetes shall be investigated in a randomized single-blinded investigator cross-over design please compare design description
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None