Effect of 10-day Overnight Hypoxia Treatment on Whole Body Insulin Sensitivity (SLEEP HIGH Study) (SLEEP HIGH)
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|ClinicalTrials.gov Identifier: NCT01872533|
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Insulin Resistance||Other: Hypoxia Exposure||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of 10-day Overnight Hypoxia Treatment on Whole Body Insulin Sensitivity (SLEEP HIGH Study)|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||May 2013|
Experimental: Hypoxia Exposure
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 [ Time Frame: Change from baseline to 10 nights of hypoxia exposure ]Glucose disposal and oxidation were measured using a two-step hyperinsulinemic euglycemic clamp and indirect calorimetry.
- Change in oxygen tension in adipose tissue [ Time Frame: Before and after 10 nights of hypoxia exposure ]pO2 levels were measured in adipose tissue both under hypoxia and normal oxygen conditions (normoxia) via a dual temperature-oxygen tension probe.
- Glucose uptake in myotubes [ Time Frame: Before 10 nights of hypoxia exposure ]Glucose uptake assays were performed in the presence or absence of hypoxia on myotubes harvested from muscle biopsies.
- Change in gene and protein expression [ Time Frame: Before and after 10 nights of hypoxia exposure ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872533
|United States, Louisiana|
|Pennington Biomedical Research Center|
|Baton Rouge, Louisiana, United States, 70808|