Effects of Benfotiamine and AGE on Endothelial Function in People With Diabetes (AGE-Benfo)

This study has been completed.
Sponsor:
Information provided by:
Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT00437008
First received: February 15, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Endothelial Dysfunction
Type 2 Diabetes Mellitus
Drug: Benfotiamine 1050mg, 3 days
Behavioral: high-AGE vs. low-AGE meal
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Ruhr University of Bochum:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 21
Study Start Date: November 2004
Estimated Study Completion Date: January 2006
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).

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00437008

Locations
Germany
Heart and Diabetes Center NRW
Bad Oeynhausen, Germany, 32545
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
Principal Investigator: Alin O Stirban, Dr Heart and Diabetes Center NRW
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00437008     History of Changes
Other Study ID Numbers: Benfo-1-2005
Study First Received: February 15, 2007
Last Updated: February 15, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ruhr University of Bochum:
endothelial dysfunction
flow-mediated dilatation
advanced glycation end products
postprandial

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Benphothiamine
Thiamine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 29, 2014