Back to resultsEffect of 10-day Overnight Hypoxia Treatment on Whole Body Insulin Sensitivity (SLEEP HIGH Study) (SLEEP HIGH)
Primary Purpose
Insulin Resistance
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hypoxia Exposure
Sponsored by
About this trial
This is an interventional prevention trial for Insulin Resistance focused on measuring obesity, hypoxia, insulin sensitivity, altitude
Eligibility Criteria
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
Sites / Locations
- Pennington Biomedical Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hypoxia Exposure
Arm Description
There was only one study arm: All participants slept in moderate hypoxia (see description below).
Outcomes
Primary Outcome Measures
Change in Insulin sensitivity
Glucose disposal and oxidation were measured using a two-step hyperinsulinemic euglycemic clamp and indirect calorimetry.
Secondary Outcome Measures
Change in oxygen tension in adipose tissue
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
Glucose uptake assays were performed in the presence or absence of hypoxia on myotubes harvested from muscle biopsies.
Change in gene and protein expression
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.
Full Information
NCT ID
NCT01872533
First Posted
June 3, 2013
Last Updated
December 1, 2015
Sponsor
Pennington Biomedical Research Center
1. Study Identification
Unique Protocol Identification Number
NCT01872533
Brief Title
Effect of 10-day Overnight Hypoxia Treatment on Whole Body Insulin Sensitivity (SLEEP HIGH Study)
Acronym
SLEEP HIGH
Official Title
Effect of 10-day Overnight Hypoxia Treatment on Whole Body Insulin Sensitivity (SLEEP HIGH Study)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
obesity, hypoxia, insulin sensitivity, altitude
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypoxia Exposure
Arm Type
Experimental
Arm Description
There was only one study arm: All participants slept in moderate hypoxia (see description below).
Intervention Type
Other
Intervention Name(s)
Hypoxia Exposure
Intervention Description
Participants spent 10 consecutive nights (approximately 100 hours of exposure) in a hypoxic tent at ~ 15% O2 (ca. 2400 m elevation).
Primary Outcome Measure Information:
Title
Change in Insulin sensitivity
Description
Glucose disposal and oxidation were measured using a two-step hyperinsulinemic euglycemic clamp and indirect calorimetry.
Time Frame
Change from baseline to 10 nights of hypoxia exposure
Secondary Outcome Measure Information:
Title
Change in oxygen tension in adipose tissue
Description
pO2 levels were measured in adipose tissue both under hypoxia and normal oxygen conditions (normoxia) via a dual temperature-oxygen tension probe.
Time Frame
Before and after 10 nights of hypoxia exposure
Title
Glucose uptake in myotubes
Description
Glucose uptake assays were performed in the presence or absence of hypoxia on myotubes harvested from muscle biopsies.
Time Frame
Before 10 nights of hypoxia exposure
Title
Change in gene and protein expression
Description
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.
Time Frame
Before and after 10 nights of hypoxia exposure
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24265370
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of 10-day Overnight Hypoxia Treatment on Whole Body Insulin Sensitivity (SLEEP HIGH Study)
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