Cardiometabolic Effects of Rapid Glucose Excursion (ERGE)
Primary Purpose
Diabetes Mellitus, Experimental
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
bolus glucose
continuous clucose
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus, Experimental
Eligibility Criteria
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
Sites / Locations
- Barmherzige Brüder Linz - Innere MedizinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
continous glucose
bolus (excursion)
Arm Description
continous glucose infusion (60 grams over 3 hours)
3 x 20 grams of glucose as a bolus over 6 minutes at t0, 60 minutes and 120 minutes
Outcomes
Primary Outcome Measures
Interleukin-6
measurement of the concentration of IL-6 (parameter of inflammation) in the serum over time following infusion
Secondary Outcome Measures
Full Information
NCT ID
NCT04488848
First Posted
August 7, 2019
Last Updated
January 25, 2021
Sponsor
Barmherzige Brüder Linz
1. Study Identification
Unique Protocol Identification Number
NCT04488848
Brief Title
Cardiometabolic Effects of Rapid Glucose Excursion
Acronym
ERGE
Official Title
Effect of Rapid Glucose Excursion Versus Continuous Glucose Infusion on Cardiovascular and Metabolic Parameters in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 11, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
July 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barmherzige Brüder Linz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Experimental
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
continous glucose
Arm Type
Placebo Comparator
Arm Description
continous glucose infusion (60 grams over 3 hours)
Arm Title
bolus (excursion)
Arm Type
Experimental
Arm Description
3 x 20 grams of glucose as a bolus over 6 minutes at t0, 60 minutes and 120 minutes
Intervention Type
Other
Intervention Name(s)
bolus glucose
Intervention Description
bolus Glucose
Intervention Type
Other
Intervention Name(s)
continuous clucose
Intervention Description
continuous clucose
Primary Outcome Measure Information:
Title
Interleukin-6
Description
measurement of the concentration of IL-6 (parameter of inflammation) in the serum over time following infusion
Time Frame
48 hours
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
homogeneity
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthias Heinzl, MD
Phone
+43732789721236
Email
matthias.heinzl@gmx.at
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Clodi, MD, Prof.
Phone
+43732789724305
Email
martin.clodi@clodi.at
Facility Information:
Facility Name
Barmherzige Brüder Linz - Innere Medizin
City
Linz
ZIP/Postal Code
4021
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Heinzl
Phone
+436765206829
Email
matthias.heinzl@bblinz.at
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Cardiometabolic Effects of Rapid Glucose Excursion
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