Clinical trial NCT05868785: Effect of Nocturnal Parenteral Nutrition on Bone Turnover and Energy Metabolism
Official title: The Effect of Parenteral Nutrition During Nighttime Versus Daytime on Bone Turnover and Energy Metabolism in Intestinal Failure Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intestinal Failure
Osteoporosis
Insulin Sensitivity
Keywords: Parenteral Nutrition
Intestinal Failure
Circadian misalignment
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Netherlands Organisation for Scientific Research
First posted: 2023-05-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized crossover pilot study
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Differences in bone turnover marker Procollagen 1 Intact N-Terminal Propeptide
timeFrame: Study day 1 versus study day 2
measure: Differences in bone turnover marker carboxy-terminal collagen crosslinks
timeFrame: Study day 1 versus study day 2
measure: Changes in glucose variability
timeFrame: 2 weeks versus 2 weeks
Secondary outcomes:
measure: Changes in plasma insulin
timeFrame: Study day 1 versus study day 2
measure: Changes in plasma glucagon
timeFrame: Study day 1 versus study day 2
measure: Changes in nitrogen balance
timeFrame: Study day 1 versus study day 2
measure: Changes in sleep/wake rhythm
timeFrame: 2 weeks versus 2 weeks
measure: Changes in sleep quality
timeFrame: 2 weeks versus 2 weeks
measure: Changes in clock gene expression
timeFrame: Study day 1 versus study day 2
measure: Changes in energy expenditure
timeFrame: Study day 1 versus study day 2
measure: Changes in substrate oxidation rates
timeFrame: Study day 1 versus study day 2
Other outcomes:
measure: Changes in body temperature
timeFrame: Study day 1 versus study day 2
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center
state: North Holland
Study officials:
affiliation: Amsterdam UMC, location AMC
name: G.M. vd Werf, MSc, RD
role: STUDY_DIRECTOR
References: