- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04743960
Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition
January 22, 2024 updated by: Hassan Dashti, Massachusetts General Hospital
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.
Study Overview
Status
Completed
Intervention / Treatment
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
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Parenteral nutrition will be provided during the nighttime followed by daytime.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
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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.
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Actigraphy data from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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Glucose values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds) during 12-hour cycled feeds.
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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).
|
Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
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Change in fasting insulin concentration from nighttime to daytime feeds
Time Frame: Blood draw scheduled on days 8 and 15.
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Serum insulin will be measured from fasting blood samples collected on day 8 and 15.
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Blood draw scheduled on days 8 and 15.
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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).
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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).
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Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
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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).
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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).
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Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
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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).
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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).
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Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
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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).
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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).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Hassan S Dashti, Ph.D., R.D., Massachusetts General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. 2023 Oct 1. doi: 10.1002/ncp.11077. Online ahead of print.
- 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. 2023 Dec 1:S0002-9165(23)66288-4. doi: 10.1016/j.ajcnut.2023.11.016. Online ahead of print.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 5, 2021
Primary Completion (Actual)
October 24, 2022
Study Completion (Actual)
October 24, 2022
Study Registration Dates
First Submitted
February 3, 2021
First Submitted That Met QC Criteria
February 5, 2021
First Posted (Actual)
February 8, 2021
Study Record Updates
Last Update Posted (Actual)
January 23, 2024
Last Update Submitted That Met QC Criteria
January 22, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020P003741
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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