Intestinal FailureNutriSyncNCT05868785
Effect of Nocturnal Parenteral Nutrition on Bone Turnover and Energy Metabolism
A study testing Parenteral nutrition in people with Intestinal Failure and Osteoporosis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Failure, Osteoporosis, Insulin Sensitivity
- What is being tested?
- Parenteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Jul 2023to Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam University Medical Center
Amsterdam, North Holland, 1105AZ
GM van der Werf, MSc, +31205665120, g.m.vanderwerf@amsterdamumc.nl
M.J. Serlie, prof, +31205666071, m.j.serlie@amsterdamumc.nl
About this study
Official title: The Effect of Parenteral Nutrition During Nighttime Versus Daytime on Bone Turnover and Energy Metabolism in Intestinal Failure Patients
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.
Read the detailed description
Objective: This randomized crossover pilot study aims to determine the effect of nocturnal versus daytime cyclic infusion of parenteral nutrition in adult patients with chronic intestinal failure on bone turnover, glucose metabolism, nitrogen balance, sleep and wake rhythm and clock genes expression.
This study will include 20 adult patients with chronic intestinal failure. Patients will receive nocturnal parenteral nutrition for 2 weeks (period A) and will switch to daytime parenteral nutrition (period B) for 2 weeks (random assignment). During both study periods glucose variability and sleep / wake rhythm will be measured. After both study periods, patients will be admitted to the metabolic unit for 24 hours to measure bone turnover markers, nitrogen balance, glucoregulatory hormones, energy expenditure and substrate oxidation rates and clock gene expression in leukocytes.
- Conditions
- Intestinal Failure, Osteoporosis, Insulin Sensitivity
- Being tested
- Parenteral nutrition
- Keywords
- Parenteral Nutrition, Intestinal Failure, Circadian misalignment
- Medical subject headings
- Intestinal Failure, Osteoporosis, Insulin Resistance, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenteral nutritionDietary supplement
Also called active comparator
Parenteral nutrition will be administered starting at 8 pm
Parenteral nutritionDietary supplement
Also called experimental
Parenteral nutrition will be administered starting at 8 am
| Study group | Role | What they receive |
|---|---|---|
| Nocturnal parenteral nutrition | Active comparator | Patients will receive nocturnal parenteral nutrition, starting at 8pm Receives: Dietary Supplement: Parenteral nutrition |
| Diurnal parenteral nutrition | Experimental | Patients will receive diurnal parenteral nutrition, starting at 8am Receives: Dietary Supplement: Parenteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in bone turnover marker Procollagen 1 Intact N-Terminal Propeptide
Differences in the bone turnover marker Procollagen 1 Intact N-Terminal Propeptide (ug/L)
Measured: Study day 1 versus study day 2
Differences in bone turnover marker carboxy-terminal collagen crosslinks
Differences in bone turnover marker carboxy-terminal collagen crosslinks (ng/L)
Measured: Study day 1 versus study day 2
Changes in glucose variability
Changes in glucose variability measured by a continuous glucose monitor
Measured: 2 weeks versus 2 weeks
Secondary outcomes (8)
Changes in plasma insulin
insulin (pmol/L)
Measured: Study day 1 versus study day 2
Changes in plasma glucagon
glucagon (ng/L)
Measured: Study day 1 versus study day 2
Changes in nitrogen balance
Changes in nitrogen balance by comparing output (feces/urine) versus intake (oral/enteral/parenteral)
Measured: Study day 1 versus study day 2
Changes in sleep/wake rhythm
Changes in sleep/wake rhythm measured by an actigraph
Measured: 2 weeks versus 2 weeks
Changes in sleep quality
Changes in sleep quality, measured by Visual Analogue Scale (VAS) score (scale 1-10, higher scores mean better outcome)
Measured: 2 weeks versus 2 weeks
Changes in clock gene expression
Changes in clock gene expression in leukocytes (if feasible; pilot)
Measured: Study day 1 versus study day 2
Changes in energy expenditure
Changes in energy expenditure assessed by indirect calorimetry (kcal/24h)
Measured: Study day 1 versus study day 2
Changes in substrate oxidation rates
Changes in substrate oxidation rates assessed by indirect calorimetry (percent)
Measured: Study day 1 versus study day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start13 Jul 2023
- Primary completionNov 2024 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal FailureStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized crossover pilot study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Organisation for Scientific Research
- Responsible party
- Principal investigator, Prof. Dr. Mireille JM Serlie, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- G.M. vd Werf, MSc, RD, Study director, Amsterdam UMC, location AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868785
- Sponsor's protocol ID
- 82280.018.22
- Acronym
- NutriSync
- Status last verified
- Oct 2023
- First submitted
- 21 Apr 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Non-identifiable data will be available after signing a data sharing agreement with the legal support office of the Amsterdam University Medical Center
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Parenteral Nutrition During Nighttime Versus Daytime on Bone Turnover and Energy Metabolism in Intestinal Failure Patients
- ClinicalTrials.gov ID
- NCT05868785
- Acronym / sponsor ID
- NutriSync / 82280.018.22
- Conditions
- Intestinal Failure, Osteoporosis, Insulin Sensitivity
- Keywords
- Parenteral Nutrition, Intestinal Failure, Circadian misalignment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Netherlands Organisation for Scientific Research
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective: This randomized crossover pilot study aims to determine the effect of nocturnal versus daytime cyclic infusion of parenteral nutrition in adult patients with chronic intestinal failure on bone turnover, glucose metabolism, nitrogen balance, sleep and wake rhythm and clock genes expression.
This study will include 20 adult patients with chronic intestinal failure. Patients will receive nocturnal parenteral nutrition for 2 weeks (period A) and will switch to daytime parenteral nutrition (period B) for 2 weeks (random assignment). During both study periods glucose variability and sleep / wake rhythm will be measured. After both study periods, patients will be admitted to the metabolic unit for 24 hours to measure bone turnover markers, nitrogen balance, glucoregulatory hormones, energy expenditure and substrate oxidation rates and clock gene expression in leukocytes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized crossover pilot study
| Arm | Type | Receives |
|---|---|---|
| Nocturnal parenteral nutrition | Active comparator | Dietary Supplement: Parenteral nutritionPatients will receive nocturnal parenteral nutrition, starting at 8pm |
| Diurnal parenteral nutrition | Experimental | Dietary Supplement: Parenteral nutritionPatients will receive diurnal parenteral nutrition, starting at 8am |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parenteral nutritionAlso: active comparatorParenteral nutrition will be administered starting at 8 pm | Dietary supplement | Nocturnal parenteral nutrition |
| Parenteral nutritionAlso: experimentalParenteral nutrition will be administered starting at 8 am | Dietary supplement | Diurnal parenteral nutrition |
Primary outcome
Differences in bone turnover marker Procollagen 1 Intact N-Terminal Propeptide
Time frame: Study day 1 versus study day 2
Differences in the bone turnover marker Procollagen 1 Intact N-Terminal Propeptide (ug/L)
Differences in bone turnover marker carboxy-terminal collagen crosslinks
Time frame: Study day 1 versus study day 2
Differences in bone turnover marker carboxy-terminal collagen crosslinks (ng/L)
Changes in glucose variability
Time frame: 2 weeks versus 2 weeks
Changes in glucose variability measured by a continuous glucose monitor
8 secondary outcomes
Changes in plasma insulin
Time frame: Study day 1 versus study day 2
Changes in plasma glucagon
Time frame: Study day 1 versus study day 2
Changes in nitrogen balance
Time frame: Study day 1 versus study day 2
Changes in sleep/wake rhythm
Time frame: 2 weeks versus 2 weeks
Changes in sleep quality
Time frame: 2 weeks versus 2 weeks
Changes in clock gene expression
Time frame: Study day 1 versus study day 2
Changes in energy expenditure
Time frame: Study day 1 versus study day 2
Changes in substrate oxidation rates
Time frame: Study day 1 versus study day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: Yes. Non-identifiable data will be available after signing a data sharing agreement with the legal support office of the Amsterdam University Medical Center
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
G.M. vd Werf, MSc, RD study director
Amsterdam UMC, location AMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenteral nutrition in people with Intestinal Failure and Osteoporosis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact M.J.M. Serlie, professor (+31205669111, m.j.m.serlie@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in bone turnover marker Procollagen 1 Intact N-Terminal Propeptide (time frame: Study day 1 versus study day 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.