Effect of Nocturnal Parenteral Nutrition on Bone Turnover and Energy Metabolism (NCT05868785) | Clinical Trial Compass
UnknownNot Applicable
Effect of Nocturnal Parenteral Nutrition on Bone Turnover and Energy Metabolism
Netherlands20 participantsStarted 2023-07-13
Plain-language summary
This clinical trial will study the effect of daytime versus nighttime parenteral nutrition on bone turnover, glucose variability, nitrogen balance, sleep and wake rhythm and peripheral clock gene expression in patients with chronic intestinal failure.
Who can participate
Age range
18 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:
* Home parenteral nutrition for at least 5 nights a week
* On home parenteral nutrition for more than 1 year
* No major changes in parenteral nutrition for 3 months prior to inclusion
Exclusion Criteria:
* Parenteral infusion for more than 16 h a day
* Use of bone modifying drugs in the last 2 years
* Bone fractures in the past year
* Renal insufficiency (eGFR \< 60 ml/min)
* HbA1c ≥48 mmol/ml
* Use of corticosteroids
* Shift work
* Performing intensive exercise (\> 2 hours a day and \> 3 times a week)
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
1
Differences in bone turnover marker Procollagen 1 Intact N-Terminal Propeptide
Timeframe: Study day 1 versus study day 2
2
Differences in bone turnover marker carboxy-terminal collagen crosslinks
Timeframe: Study day 1 versus study day 2
3
Changes in glucose variability
Timeframe: 2 weeks versus 2 weeks
Trial details
NCT IDNCT05868785
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)