- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00437008
Effects of Benfotiamine and AGE on Endothelial Function in People With Diabetes (AGE-Benfo)
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 Overview
Status
Conditions
Intervention / Treatment
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 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
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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Bad Oeynhausen, Germany, 32545
- Heart and Diabetes Center NRW
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- type 2 diabetes mellitus
- age: 35-70 years
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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A high-AGE meal causes a more pronounced postprandial endothelial dysfunction comparing to a low-AGE meal in people with type 2 diabetes mellitus.
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Secondary Outcome Measures
Outcome Measure |
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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.
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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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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alin O Stirban, Dr, Heart and Diabetes Center NRW
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Benfo-1-2005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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