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

Pennington Biomedical Research Center

Status and phase: Completed; Early Phase 1

Conditions: Insulin Resistance

Treatments: Other: Hypoxia Exposure

Study type: Interventional

Funder types: Other

Identifiers

NCT01872533

PBRC 11009

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

9 participants in 1 patient group

Hypoxia Exposure

Experimental group

Description:

There was only one study arm: All participants slept in moderate hypoxia (see description below).

Treatment:

Other: Hypoxia Exposure