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Benfotiamine Effect on Advanced Glycation End Products(AGEs) and Soluble Receptor for AGEs(sRAGE) in Diabetes Mellitus.

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ClinicalTrials.gov Identifier: NCT02772926
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
Claudia Luévano-Contreras, Universidad de Guanajuato

Brief Summary:

Several mechanisms have been implicated in the pathophysiology of the complications of diabetes mellitus (DM), one of them is the formation and accumulation of a heterogeneous group of compounds called advanced glycation end products (AGEs). The interaction of these compounds with their receptor, the receptor for advanced glycation end products (RAGE) triggers several signalling pathways which will lead to increase in inflammatory molecules and enhanced reactive oxygen species. In addition, to the membrane receptor RAGE, there are two soluble forms, the soluble RAGE (sRAGE) and the endogenous secretory RAGE (esRAGE), these soluble receptors are capable to bind AGEs and block the AGE-RAGE axis. It has been observed that in diabetes the needs of thiamine are increased, and it could be an inhibition of the pentose phosphate pathway (thiamine is an essential cofactor in this pathway) and activation of other metabolic pathways among them AGEs formation. It has been proposed that supplementation of benfotiamine could decreased the risk of micro and macrovascular complications, and this could be in part because a decreased in the formation of AGEs. For this reason, the objective of this study was to evaluate the effect of benfotiamine on AGEs and its soluble receptors (sRAGE) in patients with type 2 diabetes.

The specific objectives in the current study are:

  1. To evaluate and compare clinical and anthropometric characteristics in type 2 DM patients with and without benfotiamine treatment.
  2. To evaluate and compare in type 2 DM patients with and without benfotiamine treatment the following biochemical parameters: total AGEs, Carboxymethyl-lysine (CML), sRAGE, glucose, hemoglobin A1c, lipids (total cholesterol, C-HDL, C-LDL, and triglycerides).
  3. To evaluate and compare dietary data such as dietary AGEs and macro and macronutrients in type 2 DM patients with and without benfotiamine treatment.

Type of study: This is a randomized, controlled, double-blind clinical trial

Methods 34 patients will be recruited, 17 per group. After signing the inform consent subjects will be assessed for inclusion criteria. Subjects meeting the inclusion criteria and those whom accept to participate will be randomized to receive either a placebo or benfotiamine treatment for 12 weeks.

At the end of the 12 weeks all the basal assessments will be repeated.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Dietary Supplement: Benfotiamine Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Benfotiamine Effect on Advanced Glycation End Products(AGEs) and Soluble Receptors for AGEs(sRAGE) in Type 2 Diabetes Mellitus.
Actual Study Start Date : October 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
450 g per pill, 2 pills per day to get 900 mg per day
Dietary Supplement: Placebo
Placebo 900 mg per day

Active Comparator: Benfotiamine
Benfotiamine (S-Benzoylthiamine O-monophosphate) 450 mg per pill, 2 pills per day to get 900 mg per day
Dietary Supplement: Benfotiamine
Benfotiamine (S-Benzoylthiamine O-monophosphate) 900 mg per day




Primary Outcome Measures :
  1. Serum levels of Carboxymethyl-lysine [ Time Frame: 12 weeks ]
    Changes in serum levels of Carboxymethyl-lysine, a marker of AGEs, will be measured. Carboxymethyl-lysine serum levels will be measured by immunoassay and the units reported will be in milligrams per deciliter.



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Ages Eligible for Study:   40 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with type 2 diabetes:

  • With no complications
  • Not taking insulin
  • With 5 years since diagnosis
  • Not taking any vitamins
  • Not pregnant or lactating women
  • Not smoking

Exclusion Criteria:

  • Intolerance to the benfotiamine treatment
  • Lack of adherence (taking less than 80% of the pills)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772926


Locations
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Mexico
Department of Medical Sciences, University of Guanajuato, León Mexico
León, Guanajuato, Mexico, 37320
Sponsors and Collaborators
Universidad de Guanajuato
Investigators
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Principal Investigator: Ma. Eugenia Garay-Sevilla, MD Universidad de Guanajuato
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Responsible Party: Claudia Luévano-Contreras, Professor, Universidad de Guanajuato
ClinicalTrials.gov Identifier: NCT02772926    
Other Study ID Numbers: CIBIUG-P-27-2015
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Claudia Luévano-Contreras, Universidad de Guanajuato:
Benfotiamine
Advanced glycation end products
Soluble receptor for AGEs
Endogenous secretory receptor for AGEs
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Benphothiamine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action