Effects of Food Advanced Glycation Endproducts on Vascular Function in Diabetes

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Dietary Supplement: Glycated beta-lactoglobulins.; Dietary Supplement: Non-glycated beta-lactoglobulins

• Registration Number: NCT01456026
• Lead Sponsor: Profil Institut für Stoffwechselforschung GmbH

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 Timeline

• Study Start: 2009-06
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2011-10
• Study First Submitted: 2011-10-14
• Study First Submitted QC: 2011-10-18
• Last Update Submitted: 2011-10-18
• Study First Posted: 2011-10-20
• Last Update Posted: 2011-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Glycated beta-lactoglobulins	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.
Non-glycated beta-lactoglobulins	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.

Primary Outcome Measures

Name	Time	Method
Postprandial Change from Baseline in Flow Mediated Dilatation	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 Outcome Measures

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

Trial Locations

Locations (1)

Heart and Diabetes Center North-Rhine Westfalia; 🇩🇪 Bad Oeynhausen, NRW, Germany