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

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ClinicalTrials.gov Identifier: NCT01872533
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Eric Ravussin, Pennington Biomedical Research Center

Tracking Information
First Submitted Date  ICMJE June 3, 2013
First Posted Date  ICMJE June 7, 2013
Last Update Posted Date December 2, 2015
Study Start Date  ICMJE July 2011
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2013)
Change in Insulin sensitivity [ Time Frame: Change from baseline to 10 nights of hypoxia exposure ]
Glucose disposal and oxidation were measured using a two-step hyperinsulinemic euglycemic clamp and indirect calorimetry.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01872533 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2013)
  • Change in oxygen tension in adipose tissue [ Time Frame: Before and after 10 nights of hypoxia exposure ]
    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 [ Time Frame: Before 10 nights of hypoxia exposure ]
    Glucose uptake assays were performed in the presence or absence of hypoxia on myotubes harvested from muscle biopsies.
  • Change in gene and protein expression [ Time Frame: Before and after 10 nights of hypoxia exposure ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of 10-day Overnight Hypoxia Treatment on Whole Body Insulin Sensitivity (SLEEP HIGH Study)
Official Title  ICMJE Effect of 10-day Overnight Hypoxia Treatment on Whole Body Insulin Sensitivity (SLEEP HIGH Study)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Insulin Resistance
Intervention  ICMJE Other: Hypoxia Exposure
Participants spent 10 consecutive nights (approximately 100 hours of exposure) in a hypoxic tent at ~ 15% O2 (ca. 2400 m elevation).
Study Arms  ICMJE Experimental: Hypoxia Exposure
There was only one study arm: All participants slept in moderate hypoxia (see description below).
Intervention: Other: Hypoxia Exposure
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2013)
9
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01872533
Other Study ID Numbers  ICMJE PBRC 11009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eric Ravussin, Pennington Biomedical Research Center
Study Sponsor  ICMJE Pennington Biomedical Research Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pennington Biomedical Research Center
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP