NCT05868785

Effect of Nocturnal Parenteral Nutrition on Bone Turnover and Energy Metabolism

The Effect of Parenteral Nutrition During Nighttime Versus Daytime on Bone Turnover and Energy Metabolism in Intestinal Failure Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intestinal Failure
• Osteoporosis
• Insulin Sensitivity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Parenteral nutrition	Parenteral nutrition will be administered starting at 8 pm
DIETARY_SUPPLEMENT	Parenteral nutrition	Parenteral nutrition will be administered starting at 8 am

Timeline

• Start date: 2023-07-13
• Primary completion: 2024-11-01
• Completion: 2025-11-01
• First posted: 2023-05-22
• Last updated: 2023-10-23

Locations

1 site across 1 country: Netherlands