The Effect of Sleep Extension on Glucose Metabolism in Women With Previous Diagnosis of Gestational Diabetes
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
- Changes in Fasting Glucose
研究概览
简要总结
Women with a history of gestational diabetes (GDM) are at high risk of developing diabetes in the future. Sleep disturbances are emerging as risk factors for incident diabetes. The purpose of this study is to test the effects of 6-week sleep extension in women with a history of GDM and short sleep on glucose metabolism by randomized controlled study.
详细描述
The primary aim of this study is to evaluate the effects of a sleep extension intervention in non-diabetic women with a prior history of GDM and habitual short sleep duration on the outcomes of glucose metabolism. The participants will be randomized to a 6-week sleep extension intervention group, using technology-assisted sleep intervention, or a healthy living information control group. Glucose metabolism parameters will be assessed by an oral glucose tolerant test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Premenopausal women, age 18-45, with a history of GDM who currently do not have diabetes
- •At least one year post-partum
- •Reported habitual sleep duration <7h/night during work- or weekdays with a desire to sleep longer
- •Reported time spent in bed =<8 hours
- •Own a smartphone compatible with Fitbit.
- •No need to provide care at night for her child(ren), defined as >3 times a week and >30 minutes at a time
- •No history of obstructive sleep apnea, insomnia, or restless leg syndrome
排除标准
- •A1C ≥6.5%
- •Currently pregnant or planning pregnancy or breast feeding
- •Insomnia symptoms defined as severe as assessed by the Insomnia Severity Index (score ≥15)
- •Rotating shift or night shift work
- •High risk for obstructive sleep apnea screened by STOP BANG questionnaire.
- •Significant medical morbidities, such as congestive heart failure, cirrhosis, chronic obstructive pulmonary disease requiring oxygen, active treatment for cancer or psychiatric problem, history of stroke with neurological deficits, cognitive impairment, kidney failure requiring dialysis, illicit drug use.
结局指标
主要结局
Changes in Fasting Glucose
时间窗: 6 weeks
Changes in fasting glucose between baseline and 6 weeks
Sleep Duration Change
时间窗: baseline and 6 weeks
Changes in sleep duration from baseline to 6 weeks
次要结局
- HOMA-IR Change(baseline and 6 weeks)
- Change in Subjective Sleep Quality(Baseline and week 6)
研究者
Sirimon Reutrakul
Associate Professor
University of Illinois at Chicago