NCT01456026

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Jun 2009

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 20, 2011

Completed
Last Updated

October 20, 2011

Status Verified

October 1, 2011

Enrollment Period

11 months

First QC Date

October 14, 2011

Last Update Submit

October 18, 2011

Conditions

Type 2 Diabetes Mellitus

Keywords

DiabetesAdvanced glycation endproductsEndothelium

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

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

    Baseline, 90 and 180 min. following food AGE intake.

Study Arms (2)

Glycated beta-lactoglobulins

EXPERIMENTAL

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.

Dietary Supplement: Glycated beta-lactoglobulins.

Non-glycated beta-lactoglobulins

ACTIVE COMPARATOR

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.

Dietary Supplement: Non-glycated beta-lactoglobulins

Interventions

Glycated beta-lactoglobulins.DIETARY_SUPPLEMENT

oral, 20 g, single administration

Glycated beta-lactoglobulins
Non-glycated beta-lactoglobulinsDIETARY_SUPPLEMENT

20 g, oral, single administration,

Non-glycated beta-lactoglobulins

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus

You may not qualify if:

  • Other types of diabetes
  • Major cardiovascular complications within 6 months prior to screening
  • Major diabetes complications
  • Failure to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart and Diabetes Center North-Rhine Westfalia

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Related Publications (1)

  • 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.

    PMID: 23238657DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Alin O Stirban, M.D.

    Profil Institute for Metabolic Research GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2011

First Posted

October 20, 2011

Study Start

June 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

October 20, 2011

Record last verified: 2011-10

Locations

DE(1)