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

Early Phase 1

Completed

• Conditions: Insulin Resistance
• Interventions: Other: Hypoxia Exposure

• Registration Number: NCT01872533
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2012-09
• Study Completion: 2013-05
• Study First Submitted: 2013-06-03
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-07
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypoxia Exposure	Hypoxia Exposure	There was only one study arm: All participants slept in moderate hypoxia (see description below).

Primary Outcome Measures

Name	Time	Method
Change in Insulin sensitivity	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

Name	Time	Method
Change in gene and protein expression	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.
Change in oxygen tension in adipose tissue	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	Before 10 nights of hypoxia exposure	Glucose uptake assays were performed in the presence or absence of hypoxia on myotubes harvested from muscle biopsies.

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States