Effect of Nocturnal Parenteral Nutrition on Bone Turnover and Energy Metabolism
NCT ID: NCT05868785
Last Updated: 2023-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2023-07-13
2025-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Nocturnal parenteral nutrition
Patients will receive nocturnal parenteral nutrition, starting at 8pm
Parenteral nutrition
Parenteral nutrition will be administered starting at 8 pm
Diurnal parenteral nutrition
Patients will receive diurnal parenteral nutrition, starting at 8am
Parenteral nutrition
Parenteral nutrition will be administered starting at 8 am
Interventions
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Parenteral nutrition
Parenteral nutrition will be administered starting at 8 pm
Parenteral nutrition
Parenteral nutrition will be administered starting at 8 am
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* On home parenteral nutrition for more than 1 year
* No major changes in parenteral nutrition for 3 months prior to inclusion
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Netherlands Organisation for Scientific Research
OTHER_GOV
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Prof. Dr. Mireille JM Serlie
prof. dr.
Principal Investigators
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G.M. vd Werf, MSc, RD
Role: STUDY_DIRECTOR
Amsterdam UMC, location AMC
Locations
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Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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82280.018.22
Identifier Type: -
Identifier Source: org_study_id
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