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.

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)

Non-identifiable data will be available after signing a data sharing agreement with the legal support office of the Amsterdam University Medical Center

After publication of the study results and for a period of 15 years

Data sharing agreement with legal support office