Status:
COMPLETED
Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
ASPEN Rhoads Research Foundation
Conditions:
Feeding Patterns
Sleep
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief Summary
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 c...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
October 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04743960
Start Date
October 5 2021
End Date
October 24 2022
Last Update
September 25 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114