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

NCT00437008 | Completed Phase 4

• 1 other identifier: Benfo-1-2005
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Endothelial Dysfunction; Type 2 Diabetes Mellitus

Keywords

endothelial dysfunction; flow-mediated dilatation; advanced glycation end products; postprandial

Outcome Measures

Primary Outcomes (1)

• A high-AGE meal causes a more pronounced postprandial endothelial dysfunction comparing to a low-AGE meal in people with type 2 diabetes mellitus.

Secondary Outcomes (2)

• 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

Interventions

Benfotiamine 1050mg, 3 days DRUG

high-AGE vs. low-AGE meal BEHAVIORAL

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• type 2 diabetes mellitus
• age: 35-70 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Study Sites (1)

Heart and Diabetes Center NRW

Bad Oeynhausen, 32545, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

benphothiamine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Alin O Stirban, Dr

  Heart and Diabetes Center NRW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 15, 2007
• First Posted: February 19, 2007
• Study Start: November 1, 2004
• Study Completion: January 1, 2006
• Last Updated: February 19, 2007

Record last verified: 2007-02

Locations

DE (1)