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

NCT03541239 | Completed DMC

• 1 other identifier: 1-10-72-298-15
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischemia Reperfusion Injury; Ischaemia Reperfusion Injury

Outcome Measures

Primary Outcomes (4)

• Changes in the amount of immune cells in the peripheral blood

  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.

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

• Changes in inflammatory cytokines in the peripheral blood

  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.

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

• Changes in intracellular activation markers in T-cells

  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.

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

• Changes in intracellular activation markers in monocytes

  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.

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

Secondary Outcomes (2)

• Measure pulse variability.

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

• Measure blood pressure.

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

Study Arms (2)

non-ischemic preconditioning

ACTIVE COMPARATOR

The participants will have the cuff attached to the arm, however not be inflated for the 4 cycles of remote ischemic conditioning: 1 cycle is 5 minutes of inflation followed by 5 minutes of deflation. The ischemic reperfusion injury was induced by cuff inflation by the Single Cuff Tourniquet 8000 to 200 mmHg in the arm for 20 minutes followed by reperfusion for 15 minutes.

Device: Single Cuff Tourniquet 8000

ischemic preconditioning

EXPERIMENTAL

The blood supply to the distal part of the arm will be occluded by inflation of a single cuff to 200mmHg, by the help of the Single Cuff Tourniquet 8000, for 5 minutes separated from 5 minutes of deflation, a cycle that happens 4 times in total. The ischemic reperfusion injury was induced by cuff inflation to 200 mmHg in the arm for 20 minutes followed by reperfusion for 15 minutes.

Device: Single Cuff Tourniquet 8000

Interventions

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.

Also known as: 20-54-711, 20-54-712

ischemic preconditioning; non-ischemic preconditioning

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy and well

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• Fonden til Lægevidenskabens Fremme: collaborator
• Erasmus Medical Center: collaborator

Study Sites (1)

C-Laboratorium, Skejby Sygehus

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bente Jespersen, Professor

  Dept. of Renal Diseases, SKS, DK

  PRINCIPAL INVESTIGATOR

• Bjarne Kuno Møller, MD

  Dept. of Clinical Immunology, SKS, DK

  STUDY CHAIR

• Carla Baan, Professor

  Erasmus Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: May 30, 2018
• Study Start: March 31, 2016
• Primary Completion: July 19, 2016
• Study Completion: July 19, 2016
• Last Updated: March 22, 2019

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)