Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Food Advanced Glycation Endproducts on Vascular Function in Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01456026
Recruitment Status : Completed
First Posted : October 20, 2011
Last Update Posted : October 20, 2011
Sponsor:
Collaborators:
Heart and Diabetes Center North-Rhine Westfalia
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Profil Institut für Stoffwechselforschung GmbH

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Dietary Supplement: Glycated beta-lactoglobulins. Dietary Supplement: Non-glycated beta-lactoglobulins Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: Acute Effects of Food Advanced Glycation Endproducts on Macrovascular Function in Subjects With Type 2 Diabetes Mellitus
Study Start Date : June 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Dietary Supplement: Glycated beta-lactoglobulins.
oral, 20 g, single administration

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




Primary Outcome Measures :
  1. Postprandial Change from Baseline in Flow Mediated Dilatation [ Time Frame: Baseline, 90 and 180 min after oral intake of food AGE ]
    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.


Secondary Outcome Measures :
  1. 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. ]
    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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01456026


Locations
Layout table for location information
Germany
Heart and Diabetes Center North-Rhine Westfalia
Bad Oeynhausen, NRW, Germany, 32545
Sponsors and Collaborators
Profil Institut für Stoffwechselforschung GmbH
Heart and Diabetes Center North-Rhine Westfalia
Icahn School of Medicine at Mount Sinai
Investigators
Layout table for investigator information
Principal Investigator: Alin O Stirban, M.D. Profil Institute for Metabolic Research GmbH
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier: NCT01456026    
Other Study ID Numbers: Exogene-AGE
First Posted: October 20, 2011    Key Record Dates
Last Update Posted: October 20, 2011
Last Verified: October 2011
Keywords provided by Profil Institut für Stoffwechselforschung GmbH:
Diabetes
Advanced glycation endproducts
Endothelium
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases