Impact of Exenatide on Sleep and Circadian Function in Type 2 Diabetes: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Non-REM Slow Wave Sleep
研究概览
简要总结
The investigators propose a pilot study to test the novel hypothesis that Exenatide treatment in patients with type 2 diabetes results in improved sleep duration and quality and to explore the relationship between improvements in sleep and measures of metabolic and circadian function. This project would be the first to probe the relationship between incretin hormone regulation, duration and intensity of sleep, glucose tolerance and circadian dysfunction in diabetic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of T2DM based on physician documentation according to established guidelines will be eligible.
排除标准
- •Patients with unstable cardiac, neurological or psychiatric disease
- •Women who are pregnant or report trying to get pregnant will be excluded.
- •Patients treated for obstructive sleep apnea (OSA) will be excluded.
- •Patients with established OSA will be included only if they have declined treatment of OSA.
- •Patients with morbid obesity (BMI ≥ 40 gk/m2)
- •Patients on insulin
- •Patients already taking an incretin-based drug will not be included
- •Patients with renal disease (creatinine clearance <30 ml/min), gastroparesis and history of pancreatitis will also be excluded based on known possible adverse medication side effects.
- •Patients taking an insulin secretagogue will be excluded.
- •Patients with Hemoglobin A1c values greater than or equal to 10 will be excluded.
研究组 & 干预措施
Usual T2 DM med regimen
Subjects will continue on Type 2 DM therapy but will add placebo injected subcutaneously twice daily to their regimen for a total of 6 weeks.
干预措施: Placebo (Drug)
Usual T2 DM med regimen plus Exenatide
Subjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide.
干预措施: Exenatide (Drug)
结局指标
主要结局
Non-REM Slow Wave Sleep
时间窗: baseline and after 6 weeks of treatment
Total minutes of non-REM sleep was measured
Total Amount of Slow Wave Activity
时间窗: baseline and after 6 weeks of treatment
Total amount of slow wave activity during sleep derived from laboratory polysomnogram was measured
次要结局
- Minutes of Wake After Sleep Onset During Sleep Recording(baseline and after 6 weeks of treatment)
- Severity of Obstructive Sleep Apnea(baseline and after 6 weeks of treatment)
- Sleep Efficiency During Polysomnographic Recording(baseline and after 6 weeks of treatment)
- Mean 24-h Blood Glucose Levels(baseline and after 6 weeks of treatment)