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Cardiometabolic Effects of Rapid Glucose Excursion

Effect of Rapid Glucose Excursion Versus Continuous Glucose Infusion on Cardiovascular and Metabolic Parameters in Healthy Volunteers

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04488848
Acronym
ERGE
Enrollment
10
Registered
2020-07-28
Start date
2019-04-11
Completion date
2021-07-31
Last updated
2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Experimental

Brief summary

The effects of rapid glucose excursions, induced by intravenous bolus application of glucose in healthy probands, on cardiometabolic and inflammatory parameters will be investigated

Detailed description

BACKGROUND: It is well known that people with diabetes have a five times higher risk of dying of cardiovascular death than non-diabetics. However not only hyperglycaemia per se but also glycaemic variability is currently particularly regarded as a risk factor for cardiovascular and microvascular complications. Intermittent blood sugar excursions with pronounced fluctuations between high and low values instead of constant, even increased blood sugar exposure, have been shown to be more harmful in several studies. 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.

Interventions

OTHERbolus glucose

bolus Glucose

OTHERcontinuous clucose

continuous clucose

Sponsors

Barmherzige Brüder Linz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Men aged 18 years or older with no disease history * written informed consent

Exclusion criteria

* receiving any medication * probands who suffer from infectious disease

Design outcomes

Primary

MeasureTime frameDescription
Interleukin-648 hoursmeasurement of the concentration of IL-6 (parameter of inflammation) in the serum over time following infusion

Countries

Austria

Contacts

Primary ContactMatthias Heinzl, MD
matthias.heinzl@gmx.at+43732789721236
Backup ContactMartin Clodi, MD, Prof.
martin.clodi@clodi.at+43732789724305

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026