Status:
COMPLETED
Effects of Benfotiamine and AGE on Endothelial Function in People With Diabetes
Lead Sponsor:
Ruhr University of Bochum
Conditions:
Endothelial Dysfunction
Type 2 Diabetes Mellitus
Eligibility:
All Genders
35-70 years
Phase:
PHASE4
Brief Summary
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 inten...
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...
Eligibility Criteria
Inclusion
- type 2 diabetes mellitus
- age: 35-70 years
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00437008
Start Date
November 1 2004
End Date
January 1 2006
Last Update
February 19 2007
Active Locations (1)
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1
Heart and Diabetes Center NRW
Bad Oeynhausen, Germany, 32545