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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
20
Parenteral nutrition will be administered starting at 8 pm
Parenteral nutrition will be administered starting at 8 am
Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands
RECRUITINGDifferences in bone turnover marker Procollagen 1 Intact N-Terminal Propeptide
Differences in the bone turnover marker Procollagen 1 Intact N-Terminal Propeptide (ug/L)
Time frame: 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)
Time frame: Study day 1 versus study day 2
Changes in glucose variability
Changes in glucose variability measured by a continuous glucose monitor
Time frame: 2 weeks versus 2 weeks
Changes in plasma insulin
insulin (pmol/L)
Time frame: Study day 1 versus study day 2
Changes in plasma glucagon
glucagon (ng/L)
Time frame: 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)
Time frame: Study day 1 versus study day 2
Changes in sleep/wake rhythm
Changes in sleep/wake rhythm measured by an actigraph
Time frame: 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)
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Time frame: 2 weeks versus 2 weeks
Changes in clock gene expression
Changes in clock gene expression in leukocytes (if feasible; pilot)
Time frame: Study day 1 versus study day 2
Changes in energy expenditure
Changes in energy expenditure assessed by indirect calorimetry (kcal/24h)
Time frame: Study day 1 versus study day 2
Changes in substrate oxidation rates
Changes in substrate oxidation rates assessed by indirect calorimetry (percent)
Time frame: Study day 1 versus study day 2