CompletedNot Applicable

Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition

United States20 participantsStarted 2021-10-05

Plain-language 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.

Who can participate

Age range

18 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in 24-hour average glucose from nighttime to daytime feeds

Timeframe: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).

Change in number of interruptions of sleep by physical movement assessed by actigraphy from nighttime to daytime feeds

Timeframe: Actigraphy data from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).

Trial details

NCT IDNCT04743960

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-24

View on ClinicalTrials.gov More Feeding Patterns trials