Effects of Food Advanced Glycation Endproducts on Vascular Function in Diabetes

Profil Institut für Stoffwechselforschung

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Dietary Supplement: Non-glycated beta-lactoglobulins; Dietary Supplement: Glycated beta-lactoglobulins.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01456026

Exogene-AGE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

19 participants in 2 patient groups

Glycated beta-lactoglobulins

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Glycated beta-lactoglobulins.

Non-glycated beta-lactoglobulins

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Non-glycated beta-lactoglobulins