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Effects of Food Advanced Glycation Endproducts on Vascular Function in Diabetes

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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

Tracking Information
First Submitted Date  ICMJE October 14, 2011
First Posted Date  ICMJE October 20, 2011
Last Update Posted Date October 20, 2011
Study Start Date  ICMJE June 2009
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2011)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 Arms  ICMJE
  • 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 * Stirban A, Kotsi P, Franke K, Strijowski U, Cai W, Götting C, Tschoepe D. Acute macrovascular dysfunction in patients with type 2 diabetes induced by ingestion of advanced glycated β-lactoglobulins. Diabetes Care. 2013 May;36(5):1278-82. doi: 10.2337/dc12-1489. Epub 2012 Dec 13.

*   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
Actual Enrollment  ICMJE
 (submitted: October 18, 2011)
19
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2010
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01456026
Other Study ID Numbers  ICMJE Exogene-AGE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Profil Institut für Stoffwechselforschung GmbH
Study Sponsor  ICMJE Profil Institut für Stoffwechselforschung GmbH
Collaborators  ICMJE
  • Heart and Diabetes Center North-Rhine Westfalia
  • Icahn School of Medicine at Mount Sinai
Investigators  ICMJE
Principal Investigator: Alin O Stirban, M.D. Profil Institute for Metabolic Research GmbH
PRS Account 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