Healthy volunteers E83.3 W94
Conditions
Interventions
Group 1: 8 healthy subjects will travel from an altitude of 233 m above sea Level to an altitude of 2650 m above sea level, remain there vor 63 hours an then return to an altitue of 233 m above sea le
Sponsors
Universität des Saarlandes
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • normal kidney function (eGFR > 60 ml/min/1,73 m²), • women of childbearing potential must agree effective measures of birth control in the 8 weeks before participating in this study
Exclusion criteria
Exclusion criteria: • malignancy, • acute or chronic inflammatory diseases, • congestive heart failure, • chronic obstructive pulmonary disease, • coronary heart disease (previous history of myocardial infarction, coronary intervention or coronary artery bypass graft surgery), • cerebrovascular disorders (history of stroke, surgery of A. carotis or intervention on A. carotis), • peripheral artery occlusive disease, • presence or risk factors for a high altitude disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of FGF-23 (Fibroblast Growth Factor 23) (intact), and FGF-23 (carboxy-terminal). Measurement in plasma. Time and altitude of measurements: Measurement 1; Baselinemeasurement; 233 m altitude above sea level Measurement 2; 8 hours after Baselinemeasurement; 1008 m altitude above sea level Measurement 3; 11 hours after Baselinemeasurement; 2656 m altitude above sea level Measurement 4; 14 hours after Baselinemeasurement; 2656 m altitude above sea level Measurement 5; 26 hours after Baselinemeasurement; 2656 m altitude above sea level Measurement 6; 33 hours after Baselinemeasurement; 2656 m altitude above sea level Measurement 7; 50 hours after Baselinemeasurement; 2656 m altitude above sea level Measurement 8; 57 hours after Baselinemeasurement; 2656 m altitude above sea level Measurement 9; 74 hours after Baselinemeasurement; 2656 m altitude above sea level Measurement 10; 76 hours after Baselinemeasurement; 1008 m altitude above sea level Measurement 11; 83 hours after Baselinemeasurement; 233 m altitude above sea level Measurement 12; 99 hours after Baselinemeasurement; 233 m altitude above sea level | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of serum-calcitriol, serum-calcifediol, serum-creatinine, serum-phosphorus, serum-calzium, serum-parathyroid hormone, urine-creatinine, urine-calzium, urine-phosphorus. Time and altitue of measurements: Measurement 1; Baselinemeasurement; 233 m altitude above sea level Measurement 2; 8 hours after Baselinemeasurement; 1008 m altitude above sea level Measurement 3; 11 hours after Baselinemeasurement; 2656 m altitude above sea level Measurement 4; 14 hours after Baselinemeasurement; 2656 m altitude above sea level Measurement 5; 26 hours after Baselinemeasurement; 2656 m altitude above sea level Measurement 6; 33 hours after Baselinemeasurement; 2656 m altitude above sea level Measurement 7; 50 hours after Baselinemeasurement; 2656 m altitude above sea level Measurement 8; 57 hours after Baselinemeasurement; 2656 m altitude above sea level Measurement 9; 74 hours after Baselinemeasurement; 2656 m altitude above sea level Measurement 10; 76 hours after Baselinemeasurement; 1008 m altitude above sea level Measurement 11; 83 hours after Baselinemeasurement; 233 m altitude above sea level Measurement 12; 99 hours after Baselinemeasurement; 233 m altitude above sea level | — |
Countries
Germany
Contacts
Public ContactFabio Lizzi
Universität des Saarlandes
Outcome results
None listed