Boston, Massachusetts 02114

  • Short Bowel Syndrome

Purpose:

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 summary:

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.


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 three months, 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 is Available At:


Original ID:

2020P003741


NCT ID:

NCT04743960


Secondary ID:


Study Acronym:


Brief Title:

Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition


Official Title:

Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

79 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Massachusetts General Hospital


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Hassan S Dashti, Ph.D., R.D.
Principal Investigator
Massachusetts General Hospital
Primary Contact:Hassan S Dashti, Ph.D., R.D.
617-643-7167
hassan.dashti@mgh.harvard.edu
Backup Contact:Richa Saxena, Ph.D.
rsaxena@partners.org

Study Dates

Start Date:March 1, 2021
Completion Date:March 1, 2022
Completion Type:Anticipated
Primary Completion Date:March 1, 2022
Primary Completion Type:Anticipated
Verification Date:February 2021
Last Changed Date:February 5, 2021
First Received Date:February 3, 2021

Study Outcomes

Outcome Type:Primary Outcome
Measure: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).
Safety Issues:False
Description: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).
Outcome Type:Primary Outcome
Measure: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).
Safety Issues:False
Description: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 refl
Outcome Type:Secondary Outcome
Measure: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 cy
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure: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).
Safety Issues:False
Description: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).
Outcome Type:Secondary Outcome
Measure:Change in fasting insulin concentration from nighttime to daytime feeds
Time Frame:Blood draw scheduled on days 8 and 15.
Safety Issues:False
Description:Serum insulin will be measured from fasting blood samples collected on day 8 and 15.
Outcome Type:Secondary Outcome
Measure: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).
Safety Issues:False
Description: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).
Outcome Type:Secondary Outcome
Measure: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).
Safety Issues:False
Description: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).
Outcome Type:Secondary Outcome
Measure: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).
Safety Issues:False
Description: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).
Outcome Type:Secondary Outcome
Measure: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).
Safety Issues:False
Description: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).

Study Interventions

Intervention Type:Dietary Supplement
Name:Time-of-day of parenteral nutrition provision
Description:Parenteral nutrition will be provided during the nighttime followed by daytime.
Arm Name:Nighttime cycled parenteral feeds followed by dayt

Study Arms

Study Arm Type:Experimental
Arm Name:Nighttime cycled parenteral feeds followed by daytime cycled parenteral feeds
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Massachusetts General Hospital
Agency Class:Industry
Agency Type:Collaborator
Agency Name:ASPEN Rhoads Research Foundation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 03, 2021

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