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

Glucose Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05462834
• Other study ID #: IRB00329264
• Secondary ID: K23HL155730
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: November 30, 2027

Study information

• Verified date: February 2024
• Source: Johns Hopkins University
• Contact: Luu Pham, MD
• Phone: 4105502118
• Email: lpham1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: November 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Intolerance
• Hypoxia
• Respiratory Aspiration
• Sleep Apnea Syndromes
• Sleep-Disordered Breathing

Intervention

Other:
• Compressed Air
Participants will be instructed to use compressed air during sleep as a placebo control.
• Supplemental Oxygen
Participants will be instructed to use supplemental oxygen at rate of 2lpm during sleep.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins University	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), PRISMA A.B.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean glucose level	average glucose (mg/dL) during sleep assessed via continuous glucose monitoring	14 days after start of intervention
Secondary	Mean fasting glucose level	Mean fasting glucose level (mg/dL)	14 days after start of intervention
Secondary	Mean fasting insulin	Fasting insulin (U/mL)	14 days after start of intervention
Secondary	Morning blood pressure	Morning blood pressure (mmHg)	14 days after start of intervention
Secondary	Inflammatory marker interleukin-6 (IL-6)	Inflammatory marker interleukin-6 (IL-6) (pg/mL) level in plasma assessed by electrochemiluminescence as a measure of systemic inflammation	14 days after start of intervention
Secondary	Tumor Necrosis Factor alpha (TNF-a) level in blood (picogram/milliliter)	Tumor Necrosis Factor alpha level in blood as a marker of inflammation	14 days after start of intervention
Secondary	C-Reactive Protein (CRP) level in blood (mg/L)	C-Reactive Protein (CRP) level in blood as a marker of inflammation	14 days after start of intervention