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临床试验/NCT04743960
NCT04743960已完成不适用

Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年10月5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
20
试验地点
2
主要终点
Change in 24-hour average glucose from nighttime to daytime feeds

研究概览

简要总结

The purpose of this study is to determine whether advancing the timing of home parenteral nutrition from overnight to daytime regimens leads to improved glucose profiles and sleep quality, and other changes in plasma metabolic signatures.

详细描述

Emerging evidence suggests that considering the time-of-day in clinical care may optimize health, partly through limiting sleep disruption and circadian misalignment. Acute sleep and circadian rhythms disturbances are associated with cardiometabolic derangements, including persistent hyperglycemia, a significant contributor to life-threatening complications. However, it is currently considered standard practice for patients on parenteral nutrition to be fed for 12-hour periods overnight. Current guidelines lack explicit guidance regarding the time-of-day when nutrition support should be administered. Thus, the overall objective of the clinical trial is to comprehensively examine a novel dimension of clinical nutrition by determining whether advancing the timing of home parenteral nutrition from overnight to daytime regimens leads to improved glucose profiles and sleep quality, and other changes in plasma metabolic signatures. The study is a 2-week controlled cross-over feeding trial where 20 short bowel syndrome patients will follow their usual overnight parenteral nutrition regimen for one week, and then advance their feeds to daytime for a second week. Patients will be assessed objectively using non-invasive, novel technologies and 'omics techniques. The investigators hypothesize that advancing the timing of home parenteral nutrition feeds to a daytime regimen is a cost-efficient, effective, and feasible nutrition timing countermeasure against metabolic derangements, fragmented sleep, and decreased quality of life. Results of this study may provide evidence-based, cost-efficient, and effective nutrition support countermeasures against hyperglycemia and sleep disruption, and could potentially modify current widespread clinical nutrition support practice.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult male or non-pregnant female volunteers (age 18-79)
  • Short bowel syndrome diagnosis
  • Able and willing to give consent and comply with study procedures
  • Currently on routine home parenteral nutrition (at least 6 months)

排除标准

  • Blind, deaf or unable to speak English
  • Women who are pregnant or nursing
  • Diabetes diagnosis or currently taking or intending to take any diabetes medication or medications influencing sugars including oral glucocorticoids, growth hormone, erythropoietin, or chemotherapeutic
  • Current use of sleep medication and melatonin
  • With skin condition that precludes wearing sensors
  • Within the last year, bariatric surgery or pregnancy
  • Within the last one month, acute infections or illnesses requiring medical attention, hospitalizations, Emergency Department visits, blood transfusions, blood loss, blood donations
  • Major changes in diet or physical activity level in the past 3 months
  • Sleep and circadian disorders (such as obstructive sleep apnea and delayed sleep phase syndrome)
  • Anticipated barriers or challenges to daytime and/or overnight cycled infusions

结局指标

主要结局

Change in 24-hour average glucose from nighttime to daytime feeds

时间窗: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).

Glucose will be continuously measured using continuous glucose sensors. Blood glucose will be averaged during each of the two 1-week feeding regimens (nighttime and daytime).

Change in number of interruptions of sleep by physical movement assessed by actigraphy from nighttime to daytime feeds

时间窗: Actigraphy data from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).

Sleep will be objectively measured from actigraphy. The number of interruptions of sleep by physical movement will be calculated as 100 × the number of groups of consecutive mobile 30-s epochs/by the total number of immobile epochs. This measure will reflect sleep quality.

次要结局

  • Change in average daily duration of glucose levels above 140 mg/dl from nighttime to daytime feeds(Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).)
  • Change in sleep duration from nighttime to daytime feeds(Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).)
  • Change in sleep midpoint from nighttime to daytime feeds(Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).)
  • Change in midpoint of most-active 10h timing from nighttime to daytime feeds(Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).)
  • Change in area under-the-curve of glucose from nighttime to daytime feeds(Glucose values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds) during 12-hour cycled feeds.)
  • Change in fasting insulin concentration from nighttime to daytime feeds(Blood draw scheduled on days 8 and 15.)
  • Change in midpoint of least-active 5h timing from nighttime to daytime feeds(Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).)

研究者

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

Hassan Dashti

Principal Investigator

Massachusetts General Hospital

研究点 (2)

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