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Effects of Food Advanced Glycation Endproducts on Vascular Function in Diabetes

NCT ID: NCT01456026

Last Updated: 2011-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-05-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Glycated beta-lactoglobulins.

Intervention Type DIETARY_SUPPLEMENT

oral, 20 g, single administration

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.

Group Type ACTIVE_COMPARATOR

Non-glycated beta-lactoglobulins

Intervention Type DIETARY_SUPPLEMENT

20 g, oral, single administration,

Interventions

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Glycated beta-lactoglobulins.

oral, 20 g, single administration

Intervention Type DIETARY_SUPPLEMENT

Non-glycated beta-lactoglobulins

20 g, oral, single administration,

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart and Diabetes Center North-Rhine Westfalia

OTHER

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role collaborator

Profil Institut für Stoffwechselforschung GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alin O Stirban, M.D.

Role: PRINCIPAL_INVESTIGATOR

Profil Institute for Metabolic Research GmbH

Locations

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Heart and Diabetes Center North-Rhine Westfalia

Bad Oeynhausen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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Stirban A, Kotsi P, Franke K, Strijowski U, Cai W, Gotting C, Tschoepe D. Acute macrovascular dysfunction in patients with type 2 diabetes induced by ingestion of advanced glycated beta-lactoglobulins. Diabetes Care. 2013 May;36(5):1278-82. doi: 10.2337/dc12-1489. Epub 2012 Dec 13.

Reference Type DERIVED
PMID: 23238657 (View on PubMed)

Other Identifiers

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Exogene-AGE

Identifier Type: -

Identifier Source: org_study_id