Double-blind Placebo-controlled Study of the Effects of Eszopiclone on Glucose Tolerance, Insulin Secretion, and Insulin Action in Adults With Chronic Insomnia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Plasma Glucose Level at the 120-minute Time Point of a 75g Oral Glucose Tolerance Test
研究概览
简要总结
Available data suggest that obtaining adequate sleep is associated with a better ability of the body to use carbohydrates as a source of energy and a lower risk of developing diabetes. The sleeping pill, Eszopiclone (Lunesta), has been approved by the Food and Drug Administration for the treatment of people who complain of trouble falling or staying asleep. This study will examine the hypothesis that the use of Eszopiclone (Lunesta) to improve the sleep of people with insomnia may also improve the use of sugar in their body.
详细描述
Study participants will complete a set of oral and intravenous glucose (sugar) tolerance tests, which will be performed on two separate occasions in random order: once after a week of treatment with Eszopiclone (Lunesta) and once again after a week of receiving placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 35 and 64
- •must have long-standing trouble falling or staying asleep
- •BMI between 22 and 34 kg/m2
排除标准
- •sleep apnea or other sleep disorder other than insomnia
- •diagnosis of diabetes requiring treatment with pills or insulin
- •night or shift work
- •presence of a medical condition that can disrupt sleep
- •women only: irregular menstrual periods or pregnancy
- •use of medications/compounds that can disrupt sleep
研究组 & 干预措施
Eszopiclone or Placebo
Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.
干预措施: Eszopiclone (Drug)
Eszopiclone or Placebo
Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.
干预措施: Placebo (Drug)
结局指标
主要结局
Plasma Glucose Level at the 120-minute Time Point of a 75g Oral Glucose Tolerance Test
时间窗: at the end of each treatment
次要结局
未报告次要终点