Effects of Food Advanced Glycation Endproducts on Vascular Function in Diabetes

This study has been completed.

Sponsor:

Collaborators:

Heart and Diabetes Center North-Rhine Westfalia

Mount Sinai School of Medicine

Information provided by (Responsible Party):

Profil Institut für Stoffwechselforschung GmbH

ClinicalTrials.gov Identifier:

NCT01456026

First received: October 14, 2011

Last updated: October 18, 2011

Last verified: October 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

October 14, 2011

Last Updated Date

October 18, 2011

Start Date ^ICMJE

June 2009

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Postprandial Change from Baseline in Flow Mediated Dilatation [ Time Frame: Baseline, 90 and 180 min after oral intake of food AGE ] [ Designated as safety issue: No ]

Macrovascular (brachial ultrasound of flow mediated dilatation -FMD) will be measured at baseline (T0), as well as 90 (T90) and 180 (T180) minutes after each beverage. The hypothesis of our study is that an AGE-rich beverage acutely impairs FMD more than a beverage with a low AGE content.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01456026 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Postprandial Change from Baseline in Microcirculation (Laser-Doppler measurements of reactive hyperemia at the hand) [ Time Frame: Baseline, 90 and 180 min. following food AGE intake. ] [ Designated as safety issue: No ]

Microvascular function will be measured at baseline (T0), as well as 90 (T90) and 180 (T180) minutes after each beverage. The hypothesis of our study is that an AGE-rich beverage acutely impairs microvascular function more than a beverage with a low AGE content.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effects of Food Advanced Glycation Endproducts on Vascular Function in Diabetes

Official Title ^ICMJE

Acute Effects of Food Advanced Glycation Endproducts on Macrovascular Function in Subjects With Type 2 Diabetes Mellitus

Brief Summary

Recent evidence supports detrimental effects of advanced glycation endproducts (AGE) on vascular function (VF). Though, the effect of AGE-modified proteins alone on vascular function remained unknown. Therefore, the aim of our study is to investigate the effects of heat-treated, glycated beta-lactoglobulins (BLG) on vascular function in subjects with type 2 diabetes mellitus (T2DM) and to compare it to non-glycated, heat-treated BLG.

Detailed Description

In a double-blind, controlled, randomized, cross-over manner, 19 subjects with T2DM will receive on 2 different days beverages containing either glycated, heat-treated BLG or non-glycated, heat-treated BLG.

Macrovascular (brachial ultrasound of flow mediated dilatation -FMD) and microvascular function (laser-doppler measurements of reactive hyperemia at the hand) at baseline (T0), as well as 90 (T90) and 180 (T180) minutes after each beverage will be measured.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)

Condition ^ICMJE

Type 2 Diabetes Mellitus

Intervention ^ICMJE

Dietary Supplement: Glycated beta-lactoglobulins.
oral, 20 g, single administration
Dietary Supplement: Non-glycated beta-lactoglobulins
20 g, oral, single administration,

Study Arm (s)

Experimental: Glycated beta-lactoglobulins
In this randomized, double blind,cross-over study, half of the subjects will receive on one day a beverage with a high AGE content and will be switched after a wash-out of min. 7 days to receive a low-AGE beverage (comparator). The other half will receive the beverages in inverse sequence.

Intervention: Dietary Supplement: Glycated beta-lactoglobulins.
Active Comparator: Non-glycated beta-lactoglobulins
In this randomized, double blind,cross-over study, half of the subjects will receive on one day a beverage with a high AGE content and will be switched after a wash-out of min. 7 days to receive a low-AGE beverage (comparator). The other half will receive the beverages in inverse sequence.

Intervention: Dietary Supplement: Non-glycated beta-lactoglobulins

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2010

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Type 2 diabetes mellitus

Exclusion Criteria:

Other types of diabetes
Major cardiovascular complications within 6 months prior to screening
Major diabetes complications
Failure to give informed consent

Gender

Both

Ages

20 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01456026

Other Study ID Numbers ^ICMJE

Exogene-AGE

Has Data Monitoring Committee

Responsible Party

Profil Institut für Stoffwechselforschung GmbH

Study Sponsor ^ICMJE

Profil Institut für Stoffwechselforschung GmbH

Collaborators ^ICMJE

Heart and Diabetes Center North-Rhine Westfalia
Mount Sinai School of Medicine

Investigators ^ICMJE

Principal Investigator:

Alin O Stirban, M.D.

Profil Institute for Metabolic Research GmbH

Information Provided By

Profil Institut für Stoffwechselforschung GmbH

Verification Date

October 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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