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

Sponsor

Pennington Biomedical Research Center (Other)

Overall Status

Completed

CT.gov ID

NCT01872533

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

N/A

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 :

Jul 1, 2011

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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