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

Insulin Resistance Clinical Trial

— SLEEP HIGH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872533
• Other study ID #: PBRC 11009
• Status: Completed
• Phase: Phase 0
• First received: June 3, 2013
• Last updated: December 1, 2015
• Start date: July 2011
• Est. completion date: May 2013

Study information

• Verified date: December 2015
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: May 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

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

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Insulin sensitivity	Glucose disposal and oxidation were measured using a two-step hyperinsulinemic euglycemic clamp and indirect calorimetry.	Change from baseline to 10 nights of hypoxia exposure	No
Secondary	Change in oxygen tension in adipose tissue	pO2 levels were measured in adipose tissue both under hypoxia and normal oxygen conditions (normoxia) via a dual temperature-oxygen tension probe.	Before and after 10 nights of hypoxia exposure	No
Secondary	Glucose uptake in myotubes	Glucose uptake assays were performed in the presence or absence of hypoxia on myotubes harvested from muscle biopsies.	Before 10 nights of hypoxia exposure	No
Secondary	Change in gene and protein expression	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.	Before and after 10 nights of hypoxia exposure	No