Menopausal Sleep Fragmentation: Impact on Body Fat Gain Biomarkers in Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Normalized Serum Leptin Levels
研究概览
简要总结
This study aims to investigate the impact of menopause-related sleep fragmentation on metabolic biomarkers of body fat gain. The investigators hypothesize that experimental sleep fragmentation will result in an adverse leptin response as a metabolic biomarker for body fat gain.
详细描述
While obesity is highly prevalent in midlife and older women, with rates increasing markedly after age 40 and body fat increasing in half of women during and after the menopause transition, factors causing these changes are not well understood. Reduced total sleep time has been shown to adversely impact biomarkers of obesity, but the effect of the highly prevalent menopause-related sleep fragmentation secondary to hot flashes on metabolism and eating behaviors in humans is not known. We will use experimental paradigms to isolate the impact of menopause-related sleep disruption, as well as that of hot flashes and estrogen withdrawal, metabolic biomarkers of body fat gain and on eating behaviors, results of which will inform strategies to prevent body fat gain and improve cardio-metabolic health outcomes in women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Healthy premenopausal women 18-45 years old
- •Regular sleep schedule
- •Limited alcohol and caffeine intake
- •Regular monthly menstrual cycles
- •No lifetime history of hot flashes
- •Willingness to use approved methods of contraception during study
- •Not obese
- •Good general health
排除标准
- •Contraindication, hypersensitivity or previous adverse reaction to gonadotropin releasing hormone agonists
- •Pregnancy
- •Breastfeeding
- •Tobacco use
- •Contraindicated systemic hormone medications or centrally active medications
- •Shift workers or recent/expected time zone travel
- •Obstructive sleep apnea
- •Insomnia symptoms
- •Diagnosis of osteoporosis or osteopenia
- •Hypothalamic-pituitary-adrenal axis disorders
- •Gastric bypass, metabolic disorders, or other related conditions
- •Abnormalities on screening laboratory tests
- •Substantial hearing impairment
- •Cardiovascular illness
- •Neurological illness
- •Recent psychiatric illness or substance-use disorder
研究组 & 干预措施
Study arm
Participants completed 2 nights of unfragmented sleep followed by 3 nights of experimentally-fragmented sleep during high estradiol (E2) phase of their menstrual cycle (Sleep Block 1). A subset of participants repeated these procedures in an experimentally-induced low-E2 state (Sleep Block 2).
干预措施: Estradiol withdrawal (Drug)
Study arm
Participants completed 2 nights of unfragmented sleep followed by 3 nights of experimentally-fragmented sleep during high estradiol (E2) phase of their menstrual cycle (Sleep Block 1). A subset of participants repeated these procedures in an experimentally-induced low-E2 state (Sleep Block 2).
干预措施: Fragmented sleep (Other)
结局指标
主要结局
Normalized Serum Leptin Levels
时间窗: pre/post sleep fragmentation (3 days); pre/post estradiol withdrawal (~5 weeks)
12-hr overnight fasted AM (morning) blood samples were assayed for leptin levels on study days 2-6 under both estrogenized and estradiol-withdrawal conditions \[total: 10 samples\]. For each individual, leptin values were normalized relative to the mean baseline leptin value. Baseline was defined as the unfragmented estrogenized condition (avg. of study days 2-3 in the estrogenized condition).
次要结局
- Normalized Satiety Scores(pre/post sleep fragmentation (3 days); pre/post estradiol withdrawal (~5 weeks))
研究者
Hadine Joffe, MD MSc
Professor of Psychiatry
Brigham and Women's Hospital