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Completed

NCT Number: NCT01872533

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

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.

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Key information

Conditions

Insulin Resistance Body Weight Glucose Metabolism Disorders Hyperinsulinism Hypoxia Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypoxia Exposure

Other

Participants spent 10 consecutive nights (approximately 100 hours of exposure) in a hypoxic tent at ~ 15% O2 (ca. 2400 m elevation).

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Acronym: SLEEP HIGH

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jun 7, 2013
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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