Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition

• ClinicalTrials.gov Identifier: NCT04743960
• Recruitment Status: Completed
• First Posted: February 8, 2021
• Last Update Posted: January 23, 2024
• Sponsor: Massachusetts General Hospital
• Collaborator: ASPEN Rhoads Research Foundation
• Information provided by (Responsible Party): Hassan Dashti, Massachusetts General Hospital

Tracking Information

• First Submitted Date: February 3, 2021
• First Posted Date: February 8, 2021
• Last Update Posted Date: January 23, 2024
• Actual Study Start Date: October 5, 2021
• Actual Primary Completion Date: October 24, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 5, 2021)

• Change in 24-hour average glucose from nighttime to daytime feeds [ Time Frame: 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 [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 5, 2021)

• Change in area under-the-curve of glucose from nighttime to daytime feeds [ Time Frame: Glucose values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds) during 12-hour cycled 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).
• Change in average daily duration of glucose levels above 140 mg/dl from nighttime to daytime feeds [ Time Frame: 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. Duration of glucose levels above 140 mg/dl will be averaged during each of the two 1-week feeding regimens (nighttime and daytime).
• Change in fasting insulin concentration from nighttime to daytime feeds [ Time Frame: Blood draw scheduled on days 8 and 15. ]
  Serum insulin will be measured from fasting blood samples collected on day 8 and 15.
• Change in sleep duration from nighttime to daytime feeds [ Time Frame: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (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).
• Change in sleep midpoint from nighttime to daytime feeds [ Time Frame: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (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).
• Change in midpoint of least-active 5h timing from nighttime to daytime feeds [ Time Frame: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (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).
• Change in midpoint of most-active 10h timing from nighttime to daytime feeds [ Time Frame: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (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).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition
• Official Title: Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition
• 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 changes in plasma metabolic signatures.
• 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 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

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

Intervention

Dietary Supplement: Time-of-day of parenteral nutrition provision

Parenteral nutrition will be provided during the nighttime followed by daytime.

Study Arms

Experimental: Nighttime cycled parenteral feeds followed by daytime cycled parenteral feeds

Patients will follow nighttime feeding regimen for one week, and then advance their feeds (approximately 12 hours earlier) to daytime feeding regimen for one week.

Intervention: Dietary Supplement: Time-of-day of parenteral nutrition provision

Publications *

• 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. 2024 Apr;39(2):426-436. doi: 10.1002/ncp.11077. Epub 2023 Oct 1.
• 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 syndrome: A quasi-experimental pilot trial. Am J Clin Nutr. 2024 Feb;119(2):569-577. doi: 10.1016/j.ajcnut.2023.11.016. Epub 2023 Dec 1.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 5, 2021): 20
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 24, 2022
• Actual Primary Completion Date: October 24, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 79 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04743960
• Other Study ID Numbers: 2020P003741
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Hassan Dashti, Massachusetts General Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Massachusetts General Hospital
• Original Study Sponsor: Same as current
• Collaborators: ASPEN Rhoads Research Foundation

Investigators

• Principal Investigator: Hassan S Dashti, Ph.D., R.D.; Massachusetts General Hospital

• PRS Account: Massachusetts General Hospital
• Verification Date: January 2024