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Impact of Nocturnal Hypoxemia on Glucose in High Altitude Sleep Disordered Breathing

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Johns Hopkins University

Status

Begins enrollment in 5 months

Conditions

Sleep-Disordered Breathing
Glucose Intolerance

Treatments

Other: Compressed Air
Other: Supplemental Oxygen

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05462834
IRB00329264
K23HL155730 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

45 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

45 participants in 2 patient groups

Compressed Air then Supplemental Oxygen
Experimental group
Treatment:
Other: Supplemental Oxygen
Other: Compressed Air
Supplemental Oxygen then Compressed Air
Experimental group
Treatment:
Other: Supplemental Oxygen
Other: Compressed Air

Trial contacts and locations

0

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Central trial contact

Luu Pham, MD

Data sourced from clinicaltrials.gov

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