Effects of Benfotiamine and AGE on Endothelial Function in People With Diabetes

NCT ID: NCT00437008

Last Updated: 2007-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2006-01-31

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 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 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).

Conditions

Endothelial Dysfunction; Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Interventions

Benfotiamine 1050mg, 3 days

Intervention Type: DRUG

high-AGE vs. low-AGE meal

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruhr University of Bochum

OTHER

Sponsor Role: lead

Principal Investigators

Alin O Stirban, Dr

Role: PRINCIPAL_INVESTIGATOR

Heart and Diabetes Center NRW

Locations

Heart and Diabetes Center NRW

Bad Oeynhausen, , Germany

Countries

Germany

Other Identifiers

Benfo-1-2005

Identifier Type: -

Identifier Source: org_study_id