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| Name | Class |
|---|---|
| InCor Heart Institute | OTHER |
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Sleep apnea is a common situation that affects up to 80% of acromegalic patients. This disease is linked to disturbance on the carbohydrate metabolism increasing the rates of diabetes. The objective of this trial is to assess (with the euglycemic hyperinsulinemic clamp) the impact of the treatment of sleep apnea, with a continuous positive air pressure device (CPAP), on the insulin resistance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP treatment | Experimental | This acromegalic patients is going to have sleep apnea treated for 3 months with a with a continuous positive air pressure device (CPAP) |
|
| Nasal adhesive | Placebo Comparator | This acromegalic patients will be treated will an external nasal dilator adhesive intended to serve as a placebo treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous positive air pressure device (CPAP) | Device | After titrating the air pressure during a polysomnography test, a CPAP device will be applied to the patient, during the night, for three months. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the insulin resistance | The insulin resistance, the target of this study, will be assessed by an index obtained during the euglucaemic hyperinsulinemic clamp (EHC). This index is derived from the amount of glucose delivered to the patient during a determined period of time. The (EHC) will be performed at the beginning of the study and 90 days after the intervention. | At the beginning of the study and after 90 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess lipids profile and weight | Lipids and weight will be assessed durind the study | At the beginning of the study and after 90 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felipe HG Duarte, MD | Unit of neuroendocrinology, discipline of endocrinology, General Hospital of the University of São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of the University of São Paulo | São Paulo | São Paulo | 05403-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22666791 | Derived | Amaro AC, Duarte FH, Jallad RS, Bronstein MD, Redline S, Lorenzi-Filho G. The use of nasal dilator strips as a placebo for trials evaluating continuous positive airway pressure. Clinics (Sao Paulo). 2012;67(5):469-74. doi: 10.6061/clinics/2012(05)11. |
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| External nasal dilator adhesive | Other | An external nasal dilator adhesive will be given to patients. They will be applied on the nose and will be used for three months aiming to serve as a placebo for snoring and sleep apnea. |
|
|
| ID | Term |
|---|---|
| D000172 | Acromegaly |
| D020181 | Sleep Apnea, Obstructive |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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