Effects of Food Advanced Glycation Endproducts on Vascular Function in Diabetes

Profil Institut für Stoffwechselforschung GmbH19 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

Glycated beta-lactoglobulins.DIETARY_SUPPLEMENT

oral, 20 g, single administration

Non-glycated beta-lactoglobulinsDIETARY_SUPPLEMENT

20 g, oral, single administration,

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Heart and Diabetes Center North-Rhine Westfalia

Bad Oeynhausen, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

Postprandial Change from Baseline in Flow Mediated Dilatation

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.

Time frame: Baseline, 90 and 180 min after oral intake of food AGE

Secondary Outcomes

Postprandial Change from Baseline in Microcirculation (Laser-Doppler measurements of reactive hyperemia at the hand)

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.

Time frame: Baseline, 90 and 180 min. following food AGE intake.

Data from ClinicalTrials.gov

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