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

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05462834
• Collaborator: National Institutes of Health (NIH) (NIH), PRISMA A.B. (Other)
• Enrollment: 45
• Arms: 2
• Anticipated Duration (Months): 60

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep-Disordered Breathing; Glucose Intolerance	Other: Compressed Air; Other: Supplemental Oxygen	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: 2 intervention periods lasting 14 days, separated by a 7-day washout2 intervention periods lasting 14 days, separated by a 7-day washout
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Impact of Nocturnal Hypoxemia on Glucose in High Altitude Sleep Disordered Breathing
• Anticipated Study Start Date: Dec 1, 2022
• Anticipated Primary Completion Date: Jun 30, 2027
• Anticipated Study Completion Date: Nov 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Compressed Air then Supplemental Oxygen	Other: Compressed Air; Participants will be instructed to use compressed air during sleep as a placebo control.; Other: Supplemental Oxygen; Participants will be instructed to use supplemental oxygen at rate of 2lpm during sleep.
Experimental: Supplemental Oxygen then Compressed Air	Other: Compressed Air; Participants will be instructed to use compressed air during sleep as a placebo control.; Other: Supplemental Oxygen; Participants will be instructed to use supplemental oxygen at rate of 2lpm during sleep.

Outcome Measures

Primary Outcome Measures

1. Mean glucose level [14 days after start of intervention]

   average glucose (mg/dL) during sleep assessed via continuous glucose monitoring

Secondary Outcome Measures

1. Mean fasting glucose level [14 days after start of intervention]

   Mean fasting glucose level (mg/dL)

2. Mean fasting insulin [14 days after start of intervention]

   Fasting insulin (U/mL)

3. Morning blood pressure [14 days after start of intervention]

   Morning blood pressure (mmHg)

4. 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

5. 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

6. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Johns Hopkins University
• National Institutes of Health (NIH)
• PRISMA A.B.

Investigators

• Principal Investigator: Luu Pham, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT05462834
• Other Study ID Numbers: IRB00329264
• First Posted: Jul 18, 2022
• Last Update Posted: Jul 18, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Respiratory Aspiration; Sleep Apnea Syndromes; Glucose Intolerance; Hypoxia

Study Results

No Results Posted as of Jul 18, 2022