Obstructive Sleep Apnea and Glycemic Dysregulation in Adults With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Glycemic variability
研究概览
简要总结
The purpose of the study is to investigate the role of sleep apnea in glycemic dysregulation in adults with Type 1 diabetes.
详细描述
Obstructive sleep apnea (OSA) is a common sleep disorder characterized by recurrent collapse of upper airway during sleep, resulting in intermittent hypoxia, sleep fragmentation by transient arousals, and poor sleep quality. Continuous positive airway pressure (CPAP), applied at night, is considered the treatment of choice for persons who are diagnosed with OSA. Current evidence suggests that OSA is highly prevalent in adults with T1D and particularly those with moderate-to-severe OSA have poorer glycemic control. Our overall goal is to investigate the role OSA in glycemic dysregulation in adults with T1D.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 50 years old
- •Type 1 Diabetes on insulin pump therapy and using a CGM device with an GMI (glucose management indicator) between 5.5 and 8.5% with hemoglobin in the normal range at screening
- •Moderate to severe OSA by home sleep apnea test
排除标准
- •Regular and adherent CPAP use per clinical guidelines
- •Requiring oxygen or advanced positive airway pressure modalities during sleep
- •Having a 'fall-asleep' or 'near miss' accident in the past 6-months
- •Shift work
- •Severe hypoglycemia (≥1 episode in the past 3 months or diagnosis of hypoglycemic unawareness)
- •≥1 trip to emergency room for poor glucose management in the past 6 months
- •Proliferative retinopathy
- •Fasting triglycerides >400mg/dL,
- •Liver transaminases >2 times upper limit of normal,
- •Renal transplantation or serum creatinine >1.5 mg/dL
- •Anemia (hemoglobin <13.0g/dL in men or <11.6g/dL in women)
- •Acute coronary syndrome or stroke past 6 months
- •Severe hypertension (blood pressure>180/105 mmHg)
- •Any other significant health condition: unstable angina, heart failure requiring hospitalization in the past 6 months, significant heart block or arrhythmias, NYHA Class>2, pulmonary disease with dependence on oxygen or daily use of bronchodilators, active or chronic infection, thyroid disease and other endocrine disorders (e.g. Cushing syndrome, acromegaly)
- •Recent major surgery
- •Major psychiatric disorder
- •Subjects will also be excluded if taking medications that can confound metabolic assessments including systemic glucocorticoids, antipsychotics, thiazide diuretics, beta-blockers, daily use of aminophylline or theophylline, or use of any immunosuppressant.
- •Currently pregnant or trying to get pregnant or nursing
- •Smoking, alcohol or illegal drug abuse
研究组 & 干预措施
Untreated
No treatment for OSA
Treated: Continuous positive airway pressure (CPAP) treatment
Treatment for OSA by CPAP
干预措施: Continuous positive airway pressure (CPAP) (Device)
结局指标
主要结局
Glycemic variability
时间窗: Within 3 months of screening
Glycemic variability will be calculated using a standard metric as percent coefficient of variation (% CV) of glucose values obtained from continuous glucose monitoring (CGM).
次要结局
未报告次要终点