NCT03392701

Brief Summary

It has been recognized lately that sepsis and inflammation has an important impact on lipid metabolism and that the extent of hypocholesterolemia may even be a marker of severity of illness. However, the interplay between inflammation and the marked changes in lipid metabolism remain to be sufficiently understood. Importantly, the exact kinetics of lipid parameters in inflammatory conditions are yet to be explored. This study aims to investigate the interaction between inflammation and lipid metabolism using the human endotoxin model (LPS infusion) in ten healthy volunteers in a single blinded randomized placebo controlled cross-over design.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable sepsis

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable sepsis

Geographic Reach
1 country

1 active site

Status
completed

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

December 20, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 21, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

7 months

First QC Date

December 21, 2017

Last Update Submit

October 16, 2018

Conditions

SepsisInflammationLPSLipid Metabolism Disorder

Outcome Measures

Primary Outcomes (1)

  • lipid kinetics

    levels of lipid parameters including LDL, HDL, lipoprotein(a), apolipoprotein A1 and apoB will be measured at multiple timepoints (t0, t15, t30, t60, t120, t180, t360, 24h and 48h) in order to evaluate the detaile kinetics of lipid parameters in inflammatory condidtions

    48 hours

Study Arms (2)

LPS infusion

EXPERIMENTAL

infusion of LPS 2 ng/kg over 5 minutes

Biological: LPS infusion

Placebo

PLACEBO COMPARATOR

NaCl

Biological: LPS infusion

Interventions

LPS infusionBIOLOGICAL

infusion of LPS 2 ng/kg over 5 minutes

LPS infusionPlacebo

Eligibility Criteria

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

You may qualify if:

  • Men aged 18 to 40 years
  • Written informed consent
  • No disease history
  • non-smoker
  • BNP level within the normal range
  • Normal renal function (serum creatinine of 1.3 mg/dL and/or creatinine clearance greater than 80ml/min)

You may not qualify if:

  • Systolic blood pressure \< 90 mmHg
  • Subjects on any medication
  • History of anaphylaxis
  • 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

Location

Related Publications (3)

  • Heinzl MW, Resl M, Klammer C, Fellinger P, Schinagl L, Obendorf F, Feldbauer R, Pohlhammer J, Wagner T, Egger M, Dieplinger B, Clodi M. SUBCLINICAL KIDNEY INJURY IS CAUSED BY A MODERATE SINGLE INFLAMMATORY EVENT. Shock. 2022 Jul 1;58(1):14-19. doi: 10.1097/SHK.0000000000001942. Epub 2022 Jul 19.

    PMID: 35616594DERIVED

  • Millischer V, Heinzl M, Faka A, Resl M, Trepci A, Klammer C, Egger M, Dieplinger B, Clodi M, Schwieler L. Intravenous administration of LPS activates the kynurenine pathway in healthy male human subjects: a prospective placebo-controlled cross-over trial. J Neuroinflammation. 2021 Jul 17;18(1):158. doi: 10.1186/s12974-021-02196-x.

    PMID: 34273987DERIVED

  • Heinzl MW, Resl M, Klammer C, Egger M, Dieplinger B, Clodi M. Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Is Not Induced in Artificial Human Inflammation and Is Not Correlated with Inflammatory Response. Infect Immun. 2020 Feb 20;88(3):e00842-19. doi: 10.1128/IAI.00842-19. Print 2020 Feb 20.

    PMID: 31843964DERIVED

MeSH Terms

Conditions

SepsisInflammationLipid Metabolism Disorders

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromePathologic ProcessesPathological Conditions, Signs and SymptomsMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Matthias Heinzl, MD

    Barmherzige Brüder Linz

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prim. Univ.-Prof. Dr. Martin Clodi, Head of Internal Medicine,

Study Record Dates

First Submitted

December 21, 2017

First Posted

January 8, 2018

Study Start

December 20, 2017

Primary Completion

July 30, 2018

Study Completion

September 30, 2018

Last Updated

October 17, 2018

Record last verified: 2018-10

Locations

AU(1)