An open, mono-centre study to investigate the effect of the local application of an anti-inflammatory agent on the concentration of different cytokines in interstitial fluid af subcutaneous adipose tissue using the open-flow microperfusion technique

Phase 1

• Conditions: 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 Term: Inflammation localized; MedDRA version: 9.1 Level: LLT Classification code 10022078 Term: Injection site inflammation; MedDRA version: 9.1 Level: LLT Classification code 10045995 Term: Unspecified local infection of skin and subcutaneous tissue

• Registration Number: EUCTR2007-001205-17-AT
• Lead Sponsor: Medizinische Universität Graz_Universitätsklinik für Innere Medizin_Diabetes und Stoffwechsel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-13
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 8

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

(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

Study & Design

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