Study Results
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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UNKNOWN
NA
10 participants
INTERVENTIONAL
2019-04-11
2021-07-31
Brief Summary
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Detailed Description
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AIM: The aim of this study is to determine the effect of rapid glucose excursion versus continuous glucose infusion on cardiovascular and metabolic parameters in healthy volunteers.
METHODS/DESIGN: In this study, ten healthy male subjects will be studied on two occasions. In a random order the subjects will receive 3 times 20 grams of glucose intravenously as a bolus or, on the other occasion, 60 grams of glucose continuously over 3 hours. Cardiometabolic biomarkers will be analysed serially to analyse the effects of glucose excursions.
PROSPECT: Glycaemic variability may be a crucial factor in the development of diabetic complications, but there is currently a lack of conclusive evidence. The causes and mechanisms of these negative influences on the cardiovascular system due to high glucose variability have not been sufficiently investigated and are therefore not fully understood so far. To date, however, there have been no studies with acutely altered glucose concentrations in healthy volunteers that have investigated the effects on traditional as well as recently identified cardiovascular and metabolic biomarkers. Knowledge of such effects may improve the therapeutic strategy in diabetic patients.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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continous glucose
continous glucose infusion (60 grams over 3 hours)
continuous clucose
continuous clucose
bolus (excursion)
3 x 20 grams of glucose as a bolus over 6 minutes at t0, 60 minutes and 120 minutes
bolus glucose
bolus Glucose
Interventions
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bolus glucose
bolus Glucose
continuous clucose
continuous clucose
Eligibility Criteria
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Inclusion Criteria
* written informed consent
Exclusion Criteria
* probands who suffer from infectious disease
18 Years
40 Years
MALE
Yes
Sponsors
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Barmherzige Brüder Linz
OTHER
Responsible Party
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Locations
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Barmherzige Brüder Linz - Innere Medizin
Linz, , Austria
Countries
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Central Contacts
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Facility Contacts
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References
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Feldbauer R, Heinzl MW, Klammer C, Resl M, Pohlhammer J, Rosenberger K, Almesberger V, Obendorf F, Schinagl L, Wagner T, Egger M, Dieplinger B, Clodi M. Effect of repeated bolus and continuous glucose infusion on a panel of circulating biomarkers in healthy volunteers. PLoS One. 2022 Dec 27;17(12):e0279308. doi: 10.1371/journal.pone.0279308. eCollection 2022.
Other Identifiers
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ERGE
Identifier Type: -
Identifier Source: org_study_id
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