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临床试验/NCT04286451
NCT04286451已完成不适用

Effect of Sleep Restriction on Adipose Tissue and Skeletal Muscle Insulin Sensitivity

Pennington Biomedical Research Center2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2020年7月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
Glucose infusion rate (via 2-step hyperinsulinemic-euglycemic clamp) (in vivo)

研究概览

简要总结

Inadequate sleep is an independent risk factor for metabolic abnormalities (such as obesity, insulin resistance, and hyperglycemia). Women report sleep disruption during the menopause transition (perimenopause) and into the postmenopausal years. Sleep disruption is one of the primary reasons why midlife women seek medical care, with up to 60% reporting significant sleep disturbances (e.g., trouble falling asleep, early morning waking, and hot flashes/night sweats). Despite the majority of women experiencing sleep disruption, no study has investigated the molecular mechanisms linking sleep disruption and the changes in metabolism that coincide with menopause.

详细描述

The investigators will conduct a randomized, crossover trial investigating the effect of sleep restriction compared to habitual sleep on adipose tissue and skeletal muscle insulin sensitivity in vivo and ex vivo. The investigators will randomize up to 10 healthy postmenopausal women with overweight/obesity and ≥6.5 hours of self-reported habitual nightly sleep to 4 nights of each sleep condition (sleep restriction and habitual sleep). After the fourth night of each sleep condition, the investigators will administer a two-step hyperinsulinemic-euglycemic clamp and collect skeletal muscle and adipose tissue samples prior to insulin infusion.

The overarching hypothesis is that sleep restriction will reduce skeletal muscle and adipose tissue insulin sensitivity compared to habitual sleep.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Double (Investigator, Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Glucose infusion rate (via 2-step hyperinsulinemic-euglycemic clamp) (in vivo)

时间窗: 4 days

Insulin sensitivity by a 2-step hyperinsulinemic euglycemic clamp is performed at the end sleep conditions.

次要结局

  • Adipose tissue insulin sensitivity (via free fatty acid area-under-the-curve during the low-dose clamp) (in vivo)(4 days)
  • Insulin-dependent suppression of lipolysis (via ex vivo adipose tissue biopsy analyses)(4 days)
  • Gene expression (via ex vivo skeletal muscle biopsy analyses with RNASeq and RT-PCR)(4 days)
  • Insulin Area-Under-The-Curve (via 2-hour standard meal test)(4 days)
  • Blood pressure (via 24-hour ambulatory blood pressure monitoring)(24 hours)
  • Glucose Area-Under-The-Curve (via 2-hour standard meal test)(4 days)
  • Resting metabolic rate (via indirect calorimetry)(4 days)
  • Fat oxidation and substrate switching (via ex vivo skeletal muscle biopsy analyses)(4 days)
  • Insulin sensitivity (via ex vivo skeletal muscle biopsy analyses)(4 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prachi Singh

Associate Professor

Pennington Biomedical Research Center

研究点 (2)

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