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Completed

NCT Number: NCT03541239

Immune Modulation by Ischemic Pre-conditioning in Healthy Individuals: Intracellular Signalling in Regulatory Cells

The aim of the study is to investigate how phosphorylation of STAT3, p38 mitogen-activated protein kinase (MAPK), extracellular signal-regulated kinase (ERK) and protein kinase B (AKT) reacts to remote ischemic conditioning (rIC) in healthy humans, which could point to mechanisms by which rIC may protect against ischemia-reperfusion injury (IRI), and if rIC affects immune reactivity.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

C-Laboratorium, Skejby Sygehus

Aarhus N, 8200, Denmark

About this study

In rIC brief episodes of non-lethal ischemia and reperfusion in one vascular bed, tissue or organ, has shown to have protective effects against IRI in various organs. The protective effect of rIC seems convincing, but to date it is not clear which mechanisms give rIC its effects, and why effects are absent in some situations. Effects of rIC on the immune system are also not clear, but important if rIC is used in transplantation and autoimmunity settings, and also in regards to infection risk. Patients studied have often been given medical treatment and/or have comorbidities affecting the results.

This project will measure how intracellular phosphorylation of STAT3, p38 MAPK, ERK and AKT, inflammatory cell patterns and cytokine production react to rIC in healthy humans, and potentially give a better understanding of the mechanisms that mediate the protective effects of rIC. The intracellular mediators studied are involved in the initiation of cytokine production and regulate apoptosis and activation of the inflammatory cells. An altered balance between leucocytes and their mediators could be of importance for rIC effects, particularly in transplantation and autoimmunity, and this will be elucidated in our study.

As a secondary end point the investigators will measure the effect of rIC on pulse variability and blood pressure using a non-invasive device, since evidence regarding these aspects is sparse, although documented positive effects of rIC have primarily been on the heart and vascular system.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy and well

Exclusion criteria

  • Smoker.
  • Taking regular medication.
  • Any acute, chronic or systemic disease
  • No hard physical exercise 72 hours prior to study participation.
  • No alcohol or caffein-containing drinks 24 hours prior to study participation.
  • Fasted for at least 6 hours prior to study participation.

Treatment and study plan

Single Cuff Tourniquet 8000

Device

If randomized to ischemic conditioning the cuff will be inflated as stated before. If randomized to non-ischemic conditioning the cuff will not be inflated.

Other names: 20-54-711, 20-54-712

Primary outcomes

  1. Changes in the amount of immune cells in the peripheral blood

    Time frame: Baseline before any intervention, 0 minutes and 85 minutes after IRI and 24 hours after IRI

    The investigators measured the effect of ischemic preconditioning on ischemia reperfusion injury in a randomised controlled cross-over trial with healthy participants. Peripheral blood before and after the intervention was measured.

  2. Changes in inflammatory cytokines in the peripheral blood

    Time frame: Baseline before any intervention, 85 minutes after IRI and 24 hours after IRI

    The investigators measured the effect of ischemic preconditioning on ischemia reperfusion injury in a randomised controlled cross-over trial with healthy participants. Peripheral blood before and after the intervention was measured.

  3. Changes in intracellular activation markers in T-cells

    Time frame: Baseline before any intervention, 0 minutes and 85 mins after IRI and 24 hours after IRI

    The investigators measured the effect of ischemic preconditioning on ischemia reperfusion injury in a randomised controlled cross-over trial with healthy participants. Peripheral blood before and after the intervention was measured.

  4. Changes in intracellular activation markers in monocytes

    Time frame: Baseline before any intervention, 0 minutes and 85 minutes after IRI and 24 hours after IRI

    The investigators measured the effect of ischemic preconditioning on ischemia reperfusion injury in a randomised controlled cross-over trial with healthy participants. Peripheral blood before and after the intervention was measured.

Secondary outcomes

  1. Measure pulse variability.

    Time frame: Baseline before any intervention and until 85 minutes after IRI and 24 hours.

    Pulse variability was measured during the experiment.

  2. Measure blood pressure.

    Time frame: Baseline before any intervention and until 85 minutes after IRI and 24 hours.

    Blood pressure was measured during the experiment.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Erasmus Medical Center
  • Fonden til Lægevidenskabens Fremme

Registry information

Acronym: KONDI-immun

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 30, 2018
Registry last updated
Mar 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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