Acute Effects of Food Advanced Glycation Endproducts on Macrovascular Function in Subjects With Type 2 Diabetes Mellitus
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Profil Institut für Stoffwechselforschung GmbH
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Postprandial Change from Baseline in Flow Mediated Dilatation
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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 Outcomes
- Postprandial Change from Baseline in Microcirculation (Laser-Doppler measurements of reactive hyperemia at the hand)(Baseline, 90 and 180 min. following food AGE intake.)