Effects of Food Advanced Glycation Endproducts on Vascular Function in Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Acute Effects of Food Advanced Glycation Endproducts on Macrovascular Function in Subjects With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01456026
• Other study ID #: Exogene-AGE
• Status: Completed
• Phase: N/A
• First received: October 14, 2011
• Last updated: October 18, 2011
• Start date: June 2009
• Est. completion date: May 2010

Study information

• Verified date: October 2011
• Source: Profil Institut für Stoffwechselforschung GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Glycated beta-lactoglobulins.
oral, 20 g, single administration
• Non-glycated beta-lactoglobulins
20 g, oral, single administration,

Locations

Country	Name	City	State
Germany	Heart and Diabetes Center North-Rhine Westfalia	Bad Oeynhausen	NRW

Sponsors (3)

Lead Sponsor	Collaborator
Profil Institut für Stoffwechselforschung GmbH	Heart and Diabetes Center North-Rhine Westfalia, Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 90 and 180 min after oral intake of food AGE	No
Secondary	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.	Baseline, 90 and 180 min. following food AGE intake.	No