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Time-of-day of parenteral nutrition provision for Short Bowel Syndrome
N/A
Waitlist Available
Led By Hassan S Dashti, Ph.D., R.D.
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult male or non-pregnant female volunteers (age 18-79)
Short bowel syndrome diagnosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
Awards & highlights
Study Summary
This trial is testing whether getting parenteral nutrition during the day, instead of at night, leads to better sleep and better metabolism.
Eligible Conditions
- Short Bowel Syndrome
- Diabetes
- Feeding Patterns
- Sleep
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in 24-hour average glucose from nighttime to daytime feeds
Change in number of interruptions of sleep by physical movement assessed by actigraphy from nighttime to daytime feeds
Secondary outcome measures
Change in area under-the-curve of glucose from nighttime to daytime feeds
Change in average daily duration of glucose levels above 140 mg/dl from nighttime to daytime feeds
Change in fasting insulin concentration from nighttime to daytime feeds
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Nighttime cycled parenteral feeds followed by daytime cycled parenteral feedsExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Time-of-day of parenteral nutrition provision
2021
N/A
~20
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,923 Previous Clinical Trials
13,193,531 Total Patients Enrolled
ASPEN Rhoads Research FoundationIndustry Sponsor
2 Previous Clinical Trials
12 Total Patients Enrolled
Hassan S Dashti, Ph.D., R.D.Principal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
60 Total Patients Enrolled
Frequently Asked Questions
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