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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01872533
Acronym
SLEEP HIGH
Enrollment
9
Registered
2013-06-07
Start date
2011-07-31
Completion date
2013-05-31
Last updated
2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance

Keywords

obesity, hypoxia, insulin sensitivity, altitude

Brief summary

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.

Interventions

Participants spent 10 consecutive nights (approximately 100 hours of exposure) in a hypoxic tent at \ 15% O2 (ca. 2400 m elevation).

Sponsors

Pennington Biomedical Research Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Aged 20-45 years * Male * Obese category (BMI \> 30 kg/m2) * Healthy as assessed by a self-reported health questionnaire * Non-smokers * Weight stable over the past 3 months (\<2kg fluctuation)

Exclusion criteria

* Female * Diabetes * Sleep apnea * Hypertension * History of altitude sickness * Individuals taking any chronic medications * Individuals taking any stimulants * Individuals taking beta-blockers * Individuals with chronic alcohol consumption (\>3 drinks per day) or drug abuse. * Individuals unable to abstain from caffeinated beverage or alcohol the days of study testing * Individuals with history disease or history of stroke

Design outcomes

Primary

MeasureTime frameDescription
Change in Insulin sensitivityChange from baseline to 10 nights of hypoxia exposureGlucose disposal and oxidation were measured using a two-step hyperinsulinemic euglycemic clamp and indirect calorimetry.

Secondary

MeasureTime frameDescription
Change in oxygen tension in adipose tissueBefore and after 10 nights of hypoxia exposurepO2 levels were measured in adipose tissue both under hypoxia and normal oxygen conditions (normoxia) via a dual temperature-oxygen tension probe.
Glucose uptake in myotubesBefore 10 nights of hypoxia exposureGlucose uptake assays were performed in the presence or absence of hypoxia on myotubes harvested from muscle biopsies.
Change in gene and protein expressionBefore and after 10 nights of hypoxia exposureGene 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026