An Early Phase 1 interventional study of Hypoxia Exposure in Insulin Resistance, sponsored by Pennington Biomedical Research Center. Completed at 1 site in United States. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-02.
Sponsored by Pennington Biomedical Research Center · Early Phase 1, Interventional, and Prevention
The purpose of this study is to look at how a reduction in oxygen levels (hypoxia) influences insulin sensitivity and carbohydrate metabolism. It is expected that 10 nights of exposure to moderate hypoxia (\~ 15% O2, similar to conditions at an altitude of \~7500 feet) will improve glucose metabolism.
2,025 studies on the registry are indexed under Insulin Resistance; 308 are open to participants now.
This study's enrollment of 9 is below the median of 40 across 1,587 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →Pennington Biomedical Research Center is the lead sponsor of 284 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
There was only one study arm: All participants slept in moderate hypoxia (see description below).
Other: Hypoxia Exposure
Participants spent 10 consecutive nights (approximately 100 hours of exposure) in a hypoxic tent at \~ 15% O2 (ca. 2400 m elevation).
Change in Insulin sensitivity
Glucose disposal and oxidation were measured using a two-step hyperinsulinemic euglycemic clamp and indirect calorimetry.
Time frame: Change from baseline to 10 nights of hypoxia exposure
Change in oxygen tension in adipose tissue
pO2 levels were measured in adipose tissue both under hypoxia and normal oxygen conditions (normoxia) via a dual temperature-oxygen tension probe.
Time frame: Before and after 10 nights of hypoxia exposure
Glucose uptake in myotubes
Glucose uptake assays were performed in the presence or absence of hypoxia on myotubes harvested from muscle biopsies.
Time frame: Before 10 nights of hypoxia exposure
Change in gene and protein expression
Gene and protein expression of some hypoxia-responsive and insulin-signaling markers were measured in biopsied muscle and adipose tissue via RT-PCR and Western blotting, respectively.
Time frame: Before and after 10 nights of hypoxia exposure
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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