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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HL146709-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this research study is to see if obstructive sleep apnea (OSA) is associated with abnormalities in fat metabolism. Through this research study, the Investigator will evaluate how fat is metabolized in people with and without sleep apnea, what substances the fat tissue releases, and how these substances might change the way the body uses energy and sugar.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Intervention (Aim 1) Group | No Intervention | Participants in this group will not receive an intervention and will only undergo several testing procedures conducted within 3 to 4 weeks to assess OSA severity. | |
| PAP Therapy and Lifestyle Intervention (Aim 2) Group | Experimental | Participants in the Aim 1 Group found to have moderate to severe OSA (defined as having a Apnea-Hypopnea Index (AHI) of 15.0 events/hour or more) randomized to this arm will receive the PAP therapy and Lifestyle Intervention for 12 weeks. |
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| Lifestyle Intervention Only (Aim 2) Group | Experimental | Participants in the Aim 1 Group found to have moderate to severe OSA (defined as having a Apnea-Hypopnea Index (AHI) of 15.0 events/hour or more) randomized to this arm will receive only the Lifestyle Intervention for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAP Therapy | Device | Auto-PAP device (ResMed AirsenseTM Autoset) with a heated humidifier will be provided along with an appropriate mask and connecting hose for nightly use |
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| Measure | Description | Time Frame |
|---|---|---|
| Whole body lipolysis rate | Measured using the Intravenous Glucose Tolerance Test (IVGTT) in micromoles/L/min assessed at baseline and again at 3 months | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Free Fatty Acids (FFA) Oxidation Rate | Measured using the IVGTT in micromoles/L/min assessed at baseline and again at 3 months | Up to 3 months |
| Adipocyte insulin resistance | Measured using the IVGTT in micromoles-microunits/L-ml assessed at baseline and again at 3 months |
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Aim 1 Group:
Inclusion criteria:
Exclusion criteria
Aim 2 Group:
Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naresh Punjabi, MD | Contact | 305-243-3963 | npunjabi@miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Naresh Punjabi, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Miami | Florida | 33143 | United States |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D052439 | Lipid Metabolism Disorders |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Lifestyle Counseling Intervention | Behavioral | Lifestyle intervention will include counseling on (a) education on nutrition and exercise; and (b) behavioral support for identifying lifestyle change strategies and problem-solving barriers to improve the regularity and duration of sleep. This will be conducted using brochures on weight loss and sleep hygiene |
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| Up to 3 months |
| Lipolysis suppression slope | Measured using the IVGTT in micromoles/L-min assessed at baseline and again at 3 months | Up to 3 months |
| Free fatty acid rebound slope | Measured using the IVGTT in micromoles/L-min assessed at baseline and again at 3 months | Up to 3 months |
| Free fatty acid insulin sensitivity parameter | Measured using the IVGTT in (picomoles/L x min)^-1 assessed at baseline and again at 3 months | Up to 3 months |
| Insulin sensitivity | Measured using the IVGTT in (milliunits/L x min)^-1 assessed at baseline and again at 3 months | Up to 3 months |
| Acute insulin response to glucose | Measured using the IVGTT in (milliunits/L) x minute assessed at baseline and again at 3 months | Up to 3 months |
| Glucose effectiveness | Measured using the IVGTT in per minute assessed at baseline and again at 3 months | Up to 3 months |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |