Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy
Ключови думи
Резюме
Описание
Research over the last decade has shown that obstructive sleep apnea (OSA) is a common condition in people with diabetes. Observational and experimental evidence also indicates that intermittent hypoxemia and recurrent arousals in OSA may alter glucose metabolism and worsen glycemic control. However, the impact of treating OSA with positive airway pressure (PAP) therapy on glycemic variability and control is not well defined. Adequately powered randomized clinical trials have yet to be performed to demonstrate whether PAP therapy for OSA in diabetics can improve glycemic variability (and control), decrease blood pressure, and reverse endothelial dysfunction. The overarching goal of this study is to determine whether PAP therapy for OSA in diabetics leads to improvements in (a) glycemic variability as assessed by self-monitoring of blood glucose and continuous monitoring of glucose; (b) glycosylated hemoglobin; (c) blood pressure; (d) endothelial function; (e) serum and urinary biomarkers; and (f) dyslipidemia.
Дати
| Последна проверка: | 06/30/2020 |
| Първо изпратено: | 01/13/2015 |
| Очаквано записване подадено: | 05/25/2015 |
| Първо публикувано: | 05/26/2015 |
| Изпратена последна актуализация: | 07/26/2020 |
| Последна актуализация публикувана: | 07/27/2020 |
| Действителна начална дата на проучването: | 11/30/2014 |
| Приблизителна дата на първично завършване: | 03/14/2020 |
| Очаквана дата на завършване на проучването: | 03/14/2020 |
Състояние или заболяване
Интервенция / лечение
Device: REMStar Postive Airway Pressure
Behavioral: LifeStyle Counseling
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Active Comparator: REMStar Postive Airway Pressure Positive pressure therapy is the standard of care for managing obstructive sleep apnea. | Device: REMStar Postive Airway Pressure Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea |
| Other: LifeStyle Counseling Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects. | Behavioral: LifeStyle Counseling Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects. |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 21 Years Да се 21 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - Type 2 diabetics - Age > 21 and ≤ 75 years Exclusion Criteria: - Inability to consent or commit to the required visits - Use of insulin or other injections for diabetes - Weight change of 10% in last six months - Use of oral steroids in the last six months - Pulmonary disease (i.e., COPD) - Renal or hepatic insufficiency - Recent MI or stroke (< 3 months) - Sleep-related hypoventilation - Obesity-hypoventilation syndrome - Morbid Obesity - Occupation as a commercial driver or operator of heavy machinery - Active substance use - Untreated thyroid disease - Pregnancy - Any history of seizures or other neurologic disease - Poor sleep hygiene or sleep disorder other than sleep apnea - Central sleep apnea - Variants of obstructive sleep apnea (e.g., REM-related OSA) - Participants not suitable for the study based on the clinical judgment - Use of any investigational drug within the past 30 days - Participating in another study |
Резултат
Първични изходни мерки
1. Continuous Glucose Monitoring System Standard Deviation [3 months]
Вторични изходни мерки
1. Blood pressure [3 months]
2. Endothelial Dysfunction (Reactive hyperemic index) [3 months]
3. Heart Rate Variability [3 months]
4. Epworth Sleepiness Scale [3 months]
5. Post-Pre meal increment from self-monitoring of blood glucose [3 months]
6. Glycosylated hemoglobin [3 months]
7. Continuous Glucose Monitoring System Mean Amplitude Glucose Excursion [3 months]
8. Continuous Glucose Monitoring System Standard Deviation [3 months]
9. Continuous Glucose Monitoring System Mean Glucose [3 months]
