Effects of oxygen treatment on mechanisms involved in tissue damage caused by lack of oxygen.

• Conditions: Study performed in healthy male vonlunteers.; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2014-002282-30-SE
• Lead Sponsor: County council of Ostergotland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-17
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. Male gender

2. Age 18-40 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Any chronic disease

- Any acute disease or trauma within 30 days of study inclusion

-Any regular or temporary medication within 10 days of study inclusion

- Inability to communicate, understand or follow study instructions

- Participant in another on-going interventional trial

- Previous Typhim Vi® vaccination

- Known allergy to any of the components of the intervention (Typhim Vi® and Lipitor®)

- Current smoker

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the effect of oxygen treatment on biomarkers reflecting the processes involved in myocardial ischemia-reperfusion injury.;Secondary Objective: To evaluate the effect of Atorvastatin on those biomarkers in oxygen-treated healthy volunteers with a low-grade induced inflammation.;Primary end point(s): Plasma levels of MMPs, TIMPS, markers of apoptosis, markers of inflammation and markers of oxidative stress ;Timepoint(s) of evaluation of this end point: Baseline and 3 hours, 6 hours and 8 hours after initiation of treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Levels of mRNA of markers of apoptosis, MMP-2 and TIMP-2 and markers of oxidative stress.<br><br>Platelet aggregation.;Timepoint(s) of evaluation of this end point: Baseline and 3 hours, 6 hours and 8 hours after initiation of treatment.