earned pharmacological responses on cell proliferation: Inhibiting the mTOR-signaling pathway
- Conditions
- healthy male participants
- Registration Number
- DRKS00017020
- Lead Sponsor
- niversitätsklinikum Essen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 80
Only healthy male non-smokers between the ages of 18 and 40 will be included. Each subject will be given a comprehensive medical examination at the Clinic for Infectious Diseases approximately 1 week before the start of the study (anamnesis interview, internal examination, blood test, ECG). A final examination will be carried out one week after participation in the study.
The presence of immunological, endocrine, cardiovascular, haematological and psychiatric diseases leads to exclusion from the study. Further exclusion criteria are an increased BMI (>30), allergies e.g. to substances used during the study (lactose intolerance), liver or kidney diseases, obstructive respiratory diseases, addictions or diabetes mellitus.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (A) T-cell proliferation, at the beginning and end of each conditioning phase; (B) IL2 and IL10 and IFNgamma concentrations in the cell culture supernatant (PBMCs) at the beginning and end of each conditioning phase; (C) mRNA expression of IL2 and IL10 and IFNgamma at the beginning and end of each conditioning phase; (D) Phosphorylation status of p70s6 kinase (Everolimus activity)<br>
- Secondary Outcome Measures
Name Time Method (A) cell populations (positive CD3, positive CD4, positive CD8, positive CD19 and positive CD45) per phenotype staining of whole blood, at the beginning and at the end of each conditioning phase; (B) cortisol levels in plasma and saliva, at the beginning and end of each conditioning phase; (C) catecholamines in plasma at the beginning and end of each conditioning phase; (D) psychological parameters (anxiety, well-being, stress) using psychological questionnaires (STAI, MDBF, PSQ), at the beginning and at end of each conditioning phase<br>