Human Metabolic Dynamics at Rest and During Aerobic Exercise Under Normobaric Normoxic and Moderate Hypoxic Conditions

Hypoxia Clinical Trial

Official title:

MetaboDyn- Liquid-liquid Extraction of Single Drops of Whole Capillary Blood as a Reliable Method of Measuring Metabolic Effects of Exercise: A Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03121885
• Other study ID #: MetaboDyn
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: July 2017
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim is to define in detail metabolic pathways at rest and during aerobic exercise in normal and healthy men and women under normobaric normoxic and moderate hypoxic conditions, using metabolomics technologies based on minimally invasive sampling relying on gas chromatography and mass spectrometry.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 1, 2018
• Est. primary completion date: July 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria:

• approval and written, informed consent

• healthy adults of varying fitness levels (age >18 years to 75 years)

Exclusion criteria:

• chronic illness requiring any medication

• pregnancy

• limitations regarding functioning in the hypoxic chamber

• inability to follow simple instructions

• relevant or severe abnormalities in medical history, physical examination, ECG routine laboratory parameters from blood and urine

Related Conditions & MeSH terms

• Energy Metabolism
• Hypoxia
• Metabolism and Nutrition Disorder
• Nutrition Disorders

Intervention

Behavioral:
• 30-minute movement activity
The subjects arrive in the CRU after a 12 hours overnight fast to perform a 30-minute movement activity with individually adapted exercise intensity on the treadmill.

Other:
• Hypoxia
The 30-minute movement activity on the treadmill will be completed by each subject once under normobaric normoxic and once under normobaric hypoxic conditions (equivalent to approximately 3000 meters above sea level) in a randomized episode.

Locations

Country	Name	City	State
Germany	Charité University Experimental & Clinical Research Center	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Benjamin Gollasch	Max Delbrück Center for Molecular Medicine in the Helmholtz Association (MDC) Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coefficient of variation of relative quantities of metabolites and physiological parameters related to its dynamic during exercise under normoxic and hypoxic conditions, using GC-MS.	A drop of capillary blood (20 µl) will be collected from the hyperemic earlobe for metabolomic analysis at the times t = 0 min (before starting), 10 min, 20 min and 30 min during the activity, and t = 50 and 60 min taken in the recovery phase. The oxygen saturation and heart rate will be determined at the same time points by pulse oximetry and heart rate monitoring, as well as blood gas analyses and subjective self-perception of energy availability on a quantitative scale throughout exercise.	6 months