This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04743960
Recruitment Status : Completed
First Posted : February 8, 2021
Last Update Posted : January 23, 2024
Sponsor:
Collaborator:
ASPEN Rhoads Research Foundation
Information provided by (Responsible Party):
Hassan Dashti, Massachusetts General Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Feeding Patterns Sleep Glucose Intolerance Short Bowel Syndrome Dietary Supplement: Time-of-day of parenteral nutrition provision Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition
Actual Study Start Date : October 5, 2021
Actual Primary Completion Date : October 24, 2022
Actual Study Completion Date : October 24, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.

  4. 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).

  5. 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).

  6. 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).

  7. 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).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04743960


Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
ASPEN Rhoads Research Foundation
Investigators
Layout table for investigator information
Principal Investigator: Hassan S Dashti, Ph.D., R.D. Massachusetts General Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Other Publications:

Layout table for additonal information
Responsible Party: Hassan Dashti, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04743960    
Other Study ID Numbers: 2020P003741
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: January 23, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hassan Dashti, Massachusetts General Hospital:
Parenteral Nutrition
Chrononutrition
Chronobiology
 Nutrition Support
Sleep
Metabolomics
Additional relevant MeSH terms:
Layout table for MeSH terms
Short Bowel Syndrome
Glucose Intolerance
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Postoperative Complications
Pathologic Processes
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases