Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes, Advanced glycation endproducts, Endothelium
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.
Interventions
DIETARY_SUPPLEMENTGlycated beta-lactoglobulins.
oral, 20 g, single administration
DIETARY_SUPPLEMENTNon-glycated beta-lactoglobulins
20 g, oral, single administration,
Sponsors
Heart and Diabetes Center North-Rhine Westfalia
Icahn School of Medicine at Mount Sinai
Profil Institut für Stoffwechselforschung GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Outcome results
None listed