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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL155730 | U.S. NIH Grant/Contract | View source |
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Changes in foreign component policy at NIH.
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| PRISMA A.B. | UNKNOWN |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compressed Air then Supplemental Oxygen | Experimental |
| |
| Supplemental Oxygen then Compressed Air | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compressed Air | Other | Participants will be instructed to use compressed air during sleep as a placebo control. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean glucose level | average glucose (mg/dL) during sleep assessed via continuous glucose monitoring | 14 days after start of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Mean fasting glucose level | Mean fasting glucose level (mg/dL) | 14 days after start of intervention |
| Mean fasting insulin | Fasting insulin (U/mL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luu Pham, MD | Johns Hopkins University | Principal Investigator |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D058868 | Compressed Air |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D000388 | Air |
| D001272 | Atmosphere |
| D004777 | Environment |
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2 intervention periods lasting 14 days, separated by a 7-day washout
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| Supplemental Oxygen | Other | Participants will be instructed to use supplemental oxygen at rate of 2lpm during sleep. |
|
| 14 days after start of intervention |
| Morning blood pressure | Morning blood pressure (mmHg) | 14 days after start of intervention |
| 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 |
| 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 |
| 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 |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D055669 |
| Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |