Effect of 10-day Overnight Hypoxia Treatment on Whole Body Insulin Sensitivity (SLEEP HIGH Study)
NCT ID: NCT01872533
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
EARLY_PHASE1
9 participants
INTERVENTIONAL
2011-07-31
2013-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Hypoxia Exposure
There was only one study arm: All participants slept in moderate hypoxia (see description below).
Hypoxia Exposure
Participants spent 10 consecutive nights (approximately 100 hours of exposure) in a hypoxic tent at \~ 15% O2 (ca. 2400 m elevation).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hypoxia Exposure
Participants spent 10 consecutive nights (approximately 100 hours of exposure) in a hypoxic tent at \~ 15% O2 (ca. 2400 m elevation).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
20 Years
45 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pennington Biomedical Research Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Eric Ravussin
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lecoultre V, Peterson CM, Covington JD, Ebenezer PJ, Frost EA, Schwarz JM, Ravussin E. Ten nights of moderate hypoxia improves insulin sensitivity in obese humans. Diabetes Care. 2013 Dec;36(12):e197-8. doi: 10.2337/dc13-1350. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PBRC 11009
Identifier Type: -
Identifier Source: org_study_id