N/A
N=8
Effect of 2-Week Nightly Moderate Hypoxia on Glucose Tolerance in Individuals With Type 2 Diabetes
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02513641 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Insulin Sensitivity — 1.7; 2.2 unitless
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hypoxico Altitude Training Systems (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Pennington Biomedical Research Center
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insulin Sensitivity |
1.7; 2.2 | — |
| SECONDARY Insulin Secretion |
0.6; 0.7 | — |
| SECONDARY Beta-cell Function |
0.9; 1.4 | — |
| SECONDARY 2-hour Glucose Area-under-the-curve |
501; 439 | — |
| SECONDARY 2-hour Insulin Area-under-the-curve Via Oral Glucose Tolerance Test |
180; 168 | — |
Summary
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.
Eligibility Criteria
INCLUSION CRITERIA
- 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
EXCLUSION CRITERIA
- 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
Data sourced from ClinicalTrials.gov (NCT02513641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.