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

February 15, 2024 updated by: Johns Hopkins University

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.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean glucose level
Time Frame: 14 days after start of intervention
average glucose (mg/dL) during sleep assessed via continuous glucose monitoring
14 days after start of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean fasting glucose level
Time Frame: 14 days after start of intervention
Mean fasting glucose level (mg/dL)
14 days after start of intervention
Mean fasting insulin
Time Frame: 14 days after start of intervention
Fasting insulin (U/mL)
14 days after start of intervention
Morning blood pressure
Time Frame: 14 days after start of intervention
Morning blood pressure (mmHg)
14 days after start of intervention
Inflammatory marker interleukin-6 (IL-6)
Time Frame: 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
14 days after start of intervention
Tumor Necrosis Factor alpha (TNF-a) level in blood (picogram/milliliter)
Time Frame: 14 days after start of intervention
Tumor Necrosis Factor alpha level in blood as a marker of inflammation
14 days after start of intervention
C-Reactive Protein (CRP) level in blood (mg/L)
Time Frame: 14 days after start of intervention
C-Reactive Protein (CRP) level in blood as a marker of inflammation
14 days after start of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

November 30, 2027

Study Registration Dates

First Submitted

July 14, 2022

First Submitted That Met QC Criteria

July 14, 2022

First Posted (Actual)

July 18, 2022

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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