Cardiometabolic Effects of Rapid Glucose Excursion (ERGE)

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

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

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Experimental
• Intervention / Treatment: Other: continuous clucose; Other: bolus glucose

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthias Heinzl, MD; Phone Number: +43732789721236; Email: matthias.heinzl@gmx.at
• Study Contact Backup: Name: Martin Clodi, MD, Prof.; Phone Number: +43732789724305; Email: martin.clodi@clodi.at

Study Locations

• Austria
  • Linz, Austria, 4021
    • Recruiting
    • Barmherzige Brüder Linz - Innere Medizin
    • Contact: Matthias Heinzl; Phone Number: +436765206829; Email: matthias.heinzl@bblinz.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: continous glucose; continous glucose infusion (60 grams over 3 hours)	Other: continuous clucose; continuous clucose
Experimental: bolus (excursion); 3 x 20 grams of glucose as a bolus over 6 minutes at t0, 60 minutes and 120 minutes	Other: bolus glucose; bolus Glucose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interleukin-6	measurement of the concentration of IL-6 (parameter of inflammation) in the serum over time following infusion	48 hours

Collaborators and Investigators

• Sponsor: Barmherzige Brüder Linz

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: August 7, 2019
• First Submitted That Met QC Criteria: July 26, 2020
• First Posted (Actual): July 28, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Experimental
• Other Study ID Numbers: ERGE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No