- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05462834
Impact of Nocturnal Hypoxemia on Glucose in High Altitude Sleep Disordered Breathing
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Luu Pham, MD
- Phone Number: 4105502118
- Email: lpham1@jhmi.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Luu Pham, MD, Johns Hopkins University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Apnea
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Signs and Symptoms, Respiratory
- Hyperglycemia
- Sleep Apnea Syndromes
- Respiratory Aspiration
- Glucose Intolerance
- Hypoxia
Other Study ID Numbers
- IRB00329264
- K23HL155730 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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