Cardiometabolic Effects of Rapid Glucose Excursion (ERGE)

Barmherzige Brüder Linz

Status: Unknown

Conditions: Diabetes Mellitus, Experimental

Treatments: Other: bolus glucose; Other: continuous clucose

Study type: Interventional

Funder types: Other

Identifiers

NCT04488848

ERGE

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 estimated patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups, including a placebo group

continous glucose

Placebo Comparator group

Description:

continous glucose infusion (60 grams over 3 hours)

Treatment:

Other: continuous clucose

bolus (excursion)

Experimental group

Description:

3 x 20 grams of glucose as a bolus over 6 minutes at t0, 60 minutes and 120 minutes

Treatment:

Other: bolus glucose