Sleep-Disordered Breathing, Glucose Intolerance
Conditions
Brief summary
Sleep disordered breathing is associated with impaired glucose tolerance and incident diabetes. Nocturnal hypoxemia is a potential stimulus of glucose intolerance. It is especially severe and highly prevalent in high altitude residents. Intervening on nocturnal hypoxemia may therefore improve glucose control and decrease the public health burden in high altitude populations. The objective of this study is to examine the impact of hypoxemia on glucose homeostasis in high altitude residents. The investigators will address this objective by examining the effect of supplemental oxygen on glucose in a randomized cross-over study.
Interventions
OTHERCompressed Air
Participants will be instructed to use compressed air during sleep as a placebo control.
OTHERSupplemental Oxygen
Participants will be instructed to use supplemental oxygen at rate of 2lpm during sleep.
Sponsors
National Institutes of Health (NIH)
PRISMA A.B.
National Heart, Lung, and Blood Institute (NHLBI)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
2 intervention periods lasting 14 days, separated by a 7-day washout
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Permanent residents of Puno, Peru
Exclusion criteria
* Recent travel to low altitude (\<3000 m) * Oxygen use * Pregnancy * Morbid obesity (BMI \> 40 kg/m2) * Current smoking * Diabetes * Other sleep disorders (e.g. circadian rhythm disorder or insomnia) * Use of open fires in the home (i.e. for cooking or heat) * Chronic Mountain Sickness (CMS) as defined by a daytime oxyhemoglobin saturation \< 85%, Qinghai CMS \>10 or excessive erythrocytosis as defined by hemoglobin \>19 g/dL in women or \>21 g/dL in men.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean glucose level | 14 days after start of intervention | average glucose (mg/dL) during sleep assessed via continuous glucose monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean fasting insulin | 14 days after start of intervention | Fasting insulin (U/mL) |
| Morning blood pressure | 14 days after start of intervention | Morning blood pressure (mmHg) |
| Mean fasting glucose level | 14 days after start of intervention | Mean fasting glucose level (mg/dL) |
| Tumor Necrosis Factor alpha (TNF-a) level in blood (picogram/milliliter) | 14 days after start of intervention | Tumor Necrosis Factor alpha level in blood as a marker of inflammation |
| C-Reactive Protein (CRP) level in blood (mg/L) | 14 days after start of intervention | C-Reactive Protein (CRP) level in blood as a marker of inflammation |
| Inflammatory marker interleukin-6 (IL-6) | 14 days after start of intervention | Inflammatory marker interleukin-6 (IL-6) (pg/mL) level in plasma assessed by electrochemiluminescence as a measure of systemic inflammation |
Outcome results
None listed