Effect of Nocturnal Parenteral Nutrition on Bone Turnover and Energy Metabolism (NutriSync)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Enrolling

Conditions: Osteoporosis; Intestinal Failure; Insulin Sensitivity

Treatments: Dietary Supplement: Parenteral nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT05868785

82280.018.22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Nocturnal parenteral nutrition

Active Comparator group

Description:

Patients will receive nocturnal parenteral nutrition, starting at 8pm

Treatment:

Dietary Supplement: Parenteral nutrition

Dietary Supplement: Parenteral nutrition

Diurnal parenteral nutrition

Experimental group

Description:

Patients will receive diurnal parenteral nutrition, starting at 8am

Treatment:

Dietary Supplement: Parenteral nutrition

Dietary Supplement: Parenteral nutrition