- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01872533
Effect of 10-day Overnight Hypoxia Treatment on Whole Body Insulin Sensitivity (SLEEP HIGH Study) (SLEEP HIGH)
December 1, 2015 updated by: Eric Ravussin, Pennington Biomedical Research Center
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Louisiana
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Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hypoxia Exposure
There was only one study arm: All participants slept in moderate hypoxia (see description below).
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Participants spent 10 consecutive nights (approximately 100 hours of exposure) in a hypoxic tent at ~ 15% O2 (ca.
2400 m elevation).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Insulin sensitivity
Time Frame: Change from baseline to 10 nights of hypoxia exposure
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Glucose disposal and oxidation were measured using a two-step hyperinsulinemic euglycemic clamp and indirect calorimetry.
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Change from baseline to 10 nights of hypoxia exposure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in oxygen tension in adipose tissue
Time Frame: Before and after 10 nights of hypoxia exposure
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pO2 levels were measured in adipose tissue both under hypoxia and normal oxygen conditions (normoxia) via a dual temperature-oxygen tension probe.
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Before and after 10 nights of hypoxia exposure
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Glucose uptake in myotubes
Time Frame: Before 10 nights of hypoxia exposure
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Glucose uptake assays were performed in the presence or absence of hypoxia on myotubes harvested from muscle biopsies.
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Before 10 nights of hypoxia exposure
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Change in gene and protein expression
Time Frame: Before and after 10 nights of hypoxia exposure
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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.
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Before and after 10 nights of hypoxia exposure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
June 3, 2013
First Submitted That Met QC Criteria
June 5, 2013
First Posted (Estimate)
June 7, 2013
Study Record Updates
Last Update Posted (Estimate)
December 2, 2015
Last Update Submitted That Met QC Criteria
December 1, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBRC 11009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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