- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01456026
Effects of Food Advanced Glycation Endproducts on Vascular Function in Diabetes
Acute Effects of Food Advanced Glycation Endproducts on Macrovascular Function in Subjects With Type 2 Diabetes Mellitus
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
NRW
-
Bad Oeynhausen, NRW, Germany, 32545
- Heart and Diabetes Center North-Rhine Westfalia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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.
|
20 g, oral, single administration,
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 90 and 180 min after oral intake of food AGE
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 90 and 180 min. following food AGE intake.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Alin O Stirban, M.D., Profil Institute for Metabolic Research GmbH
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Exogene-AGE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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