Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition

Sleep Clinical Trial

Official title:

Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04743960
• Other study ID #: 2020P003741
• Status: Completed
• Phase: N/A
• Start date: October 5, 2021
• Est. completion date: October 24, 2022

Study information

• Verified date: January 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 changes in plasma metabolic signatures.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 24, 2022
• Est. primary completion date: October 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Feeding Patterns
• Glucose Intolerance
• Short Bowel Syndrome
• Sleep

Intervention

Dietary Supplement:
• Time-of-day of parenteral nutrition provision
Parenteral nutrition will be provided during the nighttime followed by daytime.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	ASPEN Rhoads Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (2)

Dashti HS, Leong A, Mogensen KM, Annambhotla M, Li P, Deng H, Carey AN, Burns DL, Winkler MF, Compher C, Saxena R. Glycemic and sleep effects of daytime compared with those of overnight infusions of home parenteral nutrition in adults with short bowel syn — View Citation

Rahmoune A, Winkler MF, Saxena R, Compher C, Dashti HS. Comparison between self-reported and actigraphy-derived sleep measures in patients receiving home parenteral nutrition: Secondary analysis of observational data. Nutr Clin Pract. 2023 Oct 1. doi: 10.1002/ncp.11077. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 24-hour average glucose from nighttime to 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).	Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
Primary	Change in number of interruptions of sleep by physical movement assessed by actigraphy from nighttime to 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.	Actigraphy data from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
Secondary	Change in area under-the-curve of glucose from nighttime to daytime feeds	Glucose will be continuously measured using continuous glucose sensors. Area under-the-curve of blood glucose during the 12-hour feeds will be calculated using the trapezoid method and adjusted for baseline glucose values. Area under-the-curve of glucose will be averaged for each of the two 1-week feeding regimens (nighttime and daytime).	Glucose values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds) during 12-hour cycled feeds.
Secondary	Change in average daily duration of glucose levels above 140 mg/dl from nighttime to daytime feeds	Glucose will be continuously measured using continuous glucose sensors. Duration of glucose levels above 140 mg/dl will be averaged during each of the two 1-week feeding regimens (nighttime and daytime).	Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
Secondary	Change in fasting insulin concentration from nighttime to daytime feeds	Serum insulin will be measured from fasting blood samples collected on day 8 and 15.	Blood draw scheduled on days 8 and 15.
Secondary	Change in sleep duration from nighttime to daytime feeds	Sleep duration will be objectively measured from actigraphy and sleep logs. Duration will be averaged will be averaged during each of the two 1-week feeding regimens (nighttime and daytime).	Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
Secondary	Change in sleep midpoint from nighttime to daytime feeds	Sleep midpoint will be objectively measured from actigraphy and sleep logs. Midpoint will be averaged will be averaged during each of the two 1-week feeding regimens (nighttime and daytime).	Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
Secondary	Change in midpoint of least-active 5h timing from nighttime to daytime feeds	Measure of sleep timing as determined from actigraphy. Timing will be averaged will be averaged during each of the two 1-week feeding regimens (nighttime and daytime).	Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
Secondary	Change in midpoint of most-active 10h timing from nighttime to daytime feeds	Measure of sleep timing as determined from actigraphy. Timing will be averaged will be averaged during each of the two 1-week feeding regimens (nighttime and daytime).	Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).