Effect of 10-day Overnight Hypoxia Treatment on Whole Body Insulin Sensitivity (SLEEP HIGH Study)
SLEEP HIGH
1 other identifier
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Jul 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 3, 2013
CompletedFirst Posted
Study publicly available on registry
June 7, 2013
CompletedDecember 2, 2015
December 1, 2015
1.2 years
June 3, 2013
December 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Insulin sensitivity
Glucose disposal and oxidation were measured using a two-step hyperinsulinemic euglycemic clamp and indirect calorimetry.
Change from baseline to 10 nights of hypoxia exposure
Secondary Outcomes (3)
Change in oxygen tension in adipose tissue
Before and after 10 nights of hypoxia exposure
Glucose uptake in myotubes
Before 10 nights of hypoxia exposure
Change in gene and protein expression
Before and after 10 nights of hypoxia exposure
Study Arms (1)
Hypoxia Exposure
EXPERIMENTALThere was only one study arm: All participants slept in moderate hypoxia (see description below).
Interventions
Participants spent 10 consecutive nights (approximately 100 hours of exposure) in a hypoxic tent at \~ 15% O2 (ca. 2400 m elevation).
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
Related Publications (1)
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.
PMID: 24265370DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 3, 2013
First Posted
June 7, 2013
Study Start
July 1, 2011
Primary Completion
September 1, 2012
Study Completion
May 1, 2013
Last Updated
December 2, 2015
Record last verified: 2015-12