NCT02772926

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. 1.To evaluate and compare clinical and anthropometric characteristics in type 2 DM patients with and without benfotiamine treatment.
  2. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 16, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 7, 2017

Status Verified

June 1, 2017

Enrollment Period

1.7 years

First QC Date

April 26, 2016

Last Update Submit

June 5, 2017

Conditions

Type 2 Diabetes Mellitus

Keywords

BenfotiamineAdvanced glycation end productsSoluble receptor for AGEsEndogenous secretory receptor for AGEs

Outcome Measures

Primary Outcomes (1)

  • Serum levels of Carboxymethyl-lysine

    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.

    12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

450 g per pill, 2 pills per day to get 900 mg per day

Dietary Supplement: Placebo

Benfotiamine

ACTIVE COMPARATOR

Benfotiamine (S-Benzoylthiamine O-monophosphate) 450 mg per pill, 2 pills per day to get 900 mg per day

Dietary Supplement: Benfotiamine

Interventions

BenfotiamineDIETARY_SUPPLEMENT

Benfotiamine (S-Benzoylthiamine O-monophosphate) 900 mg per day

Benfotiamine
PlaceboDIETARY_SUPPLEMENT

Placebo 900 mg per day

Placebo

Eligibility Criteria

Age40 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Sciences, University of Guanajuato, León Mexico

León, Guanajuato, 37320, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

benphothiamine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ma. Eugenia Garay-Sevilla, MD

    Universidad de Guanajuato

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 26, 2016

First Posted

May 16, 2016

Study Start

October 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

June 7, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)