Effect of 10-day Overnight Hypoxia Treatment on Whole Body Insulin Sensitivity (SLEEP HIGH Study) (SLEEP HIGH)
|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.
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|