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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

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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Other: Hypoxia Exposure Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of 10-day Overnight Hypoxia Treatment on Whole Body Insulin Sensitivity (SLEEP HIGH Study)
Study Start Date : July 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: Hypoxia Exposure
There was only one study arm: All participants slept in moderate hypoxia (see description below).
Other: Hypoxia Exposure
Participants spent 10 consecutive nights (approximately 100 hours of exposure) in a hypoxic tent at ~ 15% O2 (ca. 2400 m elevation).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872533


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eric Ravussin, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01872533     History of Changes
Other Study ID Numbers: PBRC 11009
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: December 2015

Keywords provided by Eric Ravussin, Pennington Biomedical Research Center:
obesity
hypoxia
insulin sensitivity
altitude

Additional relevant MeSH terms:
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Insulin Resistance
Hypersensitivity
Hypoxia
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs