Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04488848 |
| Other study ID # |
ERGE |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 11, 2019 |
| Est. completion date |
July 2021 |
Study information
| Verified date |
January 2021 |
| Source |
Barmherzige Brüder Linz |
| Contact |
Matthias Heinzl, MD |
| Phone |
+43732789721236 |
| Email |
matthias.heinzl[@]gmx.at |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
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.
