Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Assess the insulin resistance
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acromegalic patients
- •Moderate to severe sleep apnea
- •Using somatostatin analogues at maximum dosage possible for at least 6 month
排除标准
- •Unstable angina or high risk for stroke
- •Hepatic or renal insufficiency
- •Uncontrolled diabetes
- •Steroids use
- •Uncontrolled hormonal deficiencies
结局指标
主要结局
Assess the insulin resistance
时间窗: At the beginning of the study and after 90 days.
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.
次要结局
- Assess lipids profile and weight(At the beginning of the study and after 90 days.)