We want to investigate the anti-inflammatory effects of local Solu-Dacortin application on the profile and the variation in time profile of inflammatory cytokines (IL-1beta, TNF alpha, IL-6, IL-8, IL-10) in the interstitial fluid of subcutaneous adipose tissue in healthy volunteers. We use open-flow microperfusion to gain direct acces to interstitial fluid in adipose tissue in humans. MedDRA version: 9.1 Level: LLT Classification code 10021959
Conditions
Interventions
Trade Name: Solu-Dacortin 25mg
Pharmaceutical Form: Intravenous infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administrati
Sponsors
Medizinische Universität Graz_Universitätsklinik für Innere Medizin_Diabetes und Stoffwechsel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Signed informed consent obtained before any study related activities. (2)Age of patients in the range from 19 to 45 years. (3)BMI 20 - 29 kg/m² 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (1)Any clinical signs of an acute inflammation as judged by the investigator. (2)Severe acute or chronic diseases (e.g. systemic lupus erythemadotes, rheumatoid arthritis). (3)Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. (4)Taking of any glucocorticoids, anti-inflammatory drugs, vasoactive substances or anticoagulation medication. (5)Diseases of the skin which could interfere with application of the catheters. (6)Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the anti-inflammatory effects of local Solu-Dacortin application on the profile and the variation in time profile of inflammatory cytokines (IL-1beta, TNF-alpha, IL-6, IL-8, IL-10) in the interstitial fluid of subcutaneous adipose tissue (SAT) in healthy volunteers. ; Secondary Objective: To compare the anti-inflammatory effects of local Solu-Dacortin application at two different times after catheter insertion on the profile and the variation in time profile of inflammatory cytokines (IL-1beta, TNF-alpha, IL-6, IL-8, IL-10) in the interstitial fluid of subcutaneous adipose tissue (SAT) in healthy volunteers. To investigate the profile and the variation in time profile of inflammatory cytokines (IL-1beta, TNF-alpha, IL-6, IL-8, IL-10) after insertion of a subcutaneous catheter during 25 hours. To compare interstitial fluid cytokine, glucose and lactate concentrations with the serum concentrations at the corresponding time points. To investigate the effect of Solu-Dacortin administration on glucose and lactate concentrations in ISF. ; Primary end point(s): Time concentration profiles of interstitial fluid concentrations of cytokines (IL-1beta, IL- 6, IL-8, IL-10, TNF-alpha) with and without Solu-Dacortin administration. | — |
Countries
Austria
Outcome results
None listed