Effect of 2-Week Nightly Moderate Hypoxia on Glucose Tolerance in Individuals With Type 2 Diabetes

Completed · Not applicable

Conditions studied: Type 2 Diabetes

In brief

The purpose of this study is to determine if 2 weeks of nightly exposure (7-12 hours per night) to moderate hypoxia (\~2,400 meters or 7,500 feet) improves glucose metabolism in people with type 2 diabetes.

Key facts

Study ID

NCT02513641

Run by

Pennington Biomedical Research Center

People needed

8

Starts

2015-12-01

Expected to finish

2020-09-01

Last updated by the study team

2020-10-12

Who can join

Age: 20 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Aged 20-65 yrs
• Body mass index (BMI) < 55 kg/m2
• Body weight 450 lbs or less (to accommodate body composition assessment)
• Have either been diagnosed with type 2 diabetes, or fasting blood glucose between 125 and 200 mg/dL, or have a hemoglobin A1c ≥ 6.5%
• Non-smokers
• Weight stable over the previous 3 months (<3 kg fluctuation)
• Known diagnosis of sleep apnea and ownership of a continuous positive airway pressure (C-PAP) device that must be worn throughout the nights spent in the tent
• If no known presence of sleep apnea, be willing to spend one night in a sleep laboratory (Louisiana Sleep Foundation) to assess presence of sleep apnea

You may not qualify if…

• Diagnosed with T2DM ≥ 15 years ago
• Pregnant Women
• Current insulin treatment
• Treatment with sulfonylureas or glitinides
• Treatment with a GLP-1 agonist
• Any other diabetes medication other than an oral agent is exclusionary unless otherwise cleared by medical investigator.
• Chronic Obstructive Pulmonary Disease (COPD)
• Congestive heart failure
• Prior severe cardiovascular events such as stroke or myocardial infarction
• If treated for T2DM with other oral agent, no change in the treatment for 1 month before the study and the duration of the study
• Previously known diagnosis of sleep apnea without ownership of a continuous positive airway pressure (C-PAP) device or agreement to use owned CPAP device during the nights spent in the tent
• Presence of sleep apnea following a positive home sleep test (HST), or have unsafe oxyhemoglobin saturation levels (less than 78%) during a one night sleep monitoring assessment conducted at the Louisiana Sleep Foundation without ownership of a continuous positive airway pressure (C-PAP) device or agreement to use owned C-PAP device during the nights spent in the tent
• History of high altitude sickness
• History of altitude sickness
• Does not have access to a bed or sleeping surface equivalent to or smaller than a queen size mattress

Where it is running

• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States
• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States

Full record on ClinicalTrials.gov

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