Cardiometabolic Effects of Rapid Glucose Excursion | NCT04488848

Studies
Cardiometabolic Effects of Rapid Glucose Excursion

NCT04488848

Sponsor

Barmherzige Brüder Linz

Status

Unknown status

Last Update Posted

Jan 27, 2021Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Diabetes Mellitus, Experimental

Interventions

bolus glucose
continuous clucose

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 11, 2019Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Jul 2021Estimated

First Submitted Date

Aug 7, 2019

First Submission Date that Met QC Criteria

Jul 26, 2020

First Posted Date

Jul 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2021

Last Update Posted Date

Jan 27, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
continous glucose	Placebo Comparator	continous glucose infusion (60 grams over 3 hours)	Other: continuous clucose
bolus (excursion)	Experimental	3 x 20 grams of glucose as a bolus over 6 minutes at t0, 60 minutes and 120 minutes	Other: bolus glucose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bolus glucose	Other	bolus Glucose	bolus (excursion)
continuous clucose

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

homogeneity

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Matthias Heinzl, MD	Contact	+43732789721236		matthias.heinzl@gmx.at
Martin Clodi, MD, Prof.	Contact	+43732789724305		martin.clodi@clodi.at

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Barmherzige Brüder Linz - Innere Medizin	Recruiting	Linz		4021	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36574434	Derived	Feldbauer R, Heinzl MW, Klammer C, Resl M, Pohlhammer J, Rosenberger K, Almesberger V, Obendorf F, Schinagl L, Wagner T, Egger M, Dieplinger B, Clodi M. Effect of repeated bolus and continuous glucose infusion on a panel of circulating biomarkers in healthy volunteers. PLoS One. 2022 Dec 27;17(12):e0279308. doi: 10.1371/journal.pone.0279308. eCollection 2022.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases