Status:
COMPLETED
Short Term Bed Rest Study: Evaluation of the Use of Artificial Gravity, Induced by Short-arm Centrifugation
Lead Sponsor:
DLR German Aerospace Center
Collaborating Sponsors:
European Space Agency
University Hospital, Angers
Conditions:
Bone Diseases, Metabolic
Acid-Base Imbalance
Eligibility:
MALE
20-45 years
Phase:
NA
Brief Summary
Randomized cross-over design with 10 male subjects and 3 campaigns to test whether the negative effects of bed rest (6º head-down tilt) on the various systems of the body and the consequences to healt...
Detailed Description
The SAG study was a single center, open-label crossover trial with healthy men conducted in three campaigns at the Institute of Aerospace Medicine, Cologne, Germany. The subjects were quasi randomize...
Eligibility Criteria
Inclusion
- • Healthy male test subjects, aged between 20 and 45 years old with a Body Mass Index (BMI) of 20 - 26 kg/m2 and a height of 158 - 190 cm (62 - 75 inches)
- 65 - 85 kg
- Not a competitive athlete
- Non-smoker, for at least six months before the start of the study
- In the position to participate in the complete study
- Demonstrable social insurance and official certificate of absence of criminal record
- Successful completion of screening examination
- Provision of Declaration on Consent at the start of the study
Exclusion
- • Drug, medication or alcohol abuse (regular consumption of more than 20-30 g alcohol/day)
- Smoking
- Vegetarian, vegan
- Migraine
- Previous psychiatric illness
- Claustrophobia
- Hiatus hernia
- Gastro-oesophageal reflux
- Diabetes mellitus
- Rheumatic illness
- Muscle or joint disorder
- Prolapse of intervertebral disk
- Pronounced orthostatic intolerance
- Hyperlipidaemia (deviations from standard values, standard values: TG \< 180 mg/dl, cumulative CH \< 200 mg/dl, HDL \> 35 mg/dl, LDL \< 160 mg/dl)
- Renal dysfunction (deviation from plasma creatinin standard values, standard value \< 1.20 mg/dl)
- Thyroid dysfunction (deviation from standard values for plasma TSH, standard value TSH 0.27 - 4.20 U/l)
- Hyperhomocysteinemia (deviation from standard value for plasma homocysteine, standard value homocysteine \>15 µmol/l)
- Hyper-, Hypouricemia (deviation from plasma uric acid standard values, age dependent standard value 3.0-6.9 mg/dl)
- Hyper-, Hypocalcemia (deviation from plasma calcium standard values, age dependent standard value 2.15-2.64 mmol/l)
- Anaemia: (\< as standard values for plasma haemoglobin, standard values for men 13.5-17.5 g/dl)
- Iron deficiency: ferritin \< 30 µg/l
- Vitamin D deficiency: D3-25-OH \< 50 ng/ml
- Blood gas values deviating from the normal values:
- pH 7.38-7.42
- pCO2 34-45 mmHg
- pO2 79-98 mmHg
- HCO3 20-28 mmol/l
- Base deviation ± 2 mmol/l
- Family history of thrombosis or positive response in thrombosis screening procedure: Biochemical analysis of the following parameter: ATIII, protein C and S activities, factor V Leiden, prothrombin mutants, lupus PTT
- Chronic back complaints
- Bone fracture in the year preceding the study
- Bone density of the femur and lower spine (L1-L4) 1.5 SD ≤ t-score
- Metal implants or other kinds of bone synthesis materials
- Participation in another clinical study within the last 2 months before start of this study
- Imprisoned at the time of the study
- Any other condition which makes the test subject unsuitable for study inclusion in the opinion of the examiner
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01820702
Start Date
November 1 2010
End Date
May 1 2011
Last Update
March 29 2013
Active Locations (1)
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1
German Aerospace Center (DLR)
Cologne, Germany, 51147