NCT04488848

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2019

Completed
12 months until next milestone

First Posted

Study publicly available on registry

July 28, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

1.7 years

First QC Date

August 7, 2019

Last Update Submit

January 25, 2021

Conditions

Diabetes Mellitus, Experimental

Outcome Measures

Primary Outcomes (1)

  • Interleukin-6

    measurement of the concentration of IL-6 (parameter of inflammation) in the serum over time following infusion

    48 hours

Study Arms (2)

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

bolus glucoseOTHER

bolus Glucose

bolus (excursion)
continuous clucoseOTHER

continuous clucose

continous glucose

Eligibility Criteria

Age18 Years - 40 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailshomogeneity
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men aged 18 years or older with no disease history
  • written informed consent

You may not qualify if:

  • receiving any medication
  • probands who suffer from infectious disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barmherzige Brüder Linz - Innere Medizin

Linz, 4021, Austria

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36574434DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Experimental

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Matthias Heinzl, MD

CONTACT

+43732789721236matthias.heinzl@gmx.at

Martin Clodi, MD, Prof.

CONTACT

+43732789724305martin.clodi@clodi.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2019

First Posted

July 28, 2020

Study Start

April 11, 2019

Primary Completion

December 31, 2020

Study Completion

July 1, 2021

Last Updated

January 27, 2021

Record last verified: 2021-01

Locations

AU(1)