Effect of Nocturnal Parenteral Nutrition on Bone Turnover and Energy Metabolism

Osteoporosis Clinical Trial

— NutriSync  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05868785
• Other study ID #: 82280.018.22
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2023
• Est. completion date: November 2025

Study information

• Verified date: October 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: M.J.M. Serlie, professor
• Phone: +31205669111
• Email: m.j.m.serlie[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Sensitivity
• Intestinal Failure
• Osteoporosis

Intervention

Dietary Supplement:
• Parenteral nutrition
Parenteral nutrition will be administered starting at 8 pm
• Parenteral nutrition
Parenteral nutrition will be administered starting at 8 am

Locations

Country	Name	City	State
Netherlands	Amsterdam University Medical Center	Amsterdam	North Holland

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Netherlands Organisation for Scientific Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in body temperature	Changes in body temperature measured by i-buttons (Celsius)	Study day 1 versus study day 2
Primary	Differences in bone turnover marker Procollagen 1 Intact N-Terminal Propeptide	Differences in the bone turnover marker Procollagen 1 Intact N-Terminal Propeptide (ug/L)	Study day 1 versus study day 2
Primary	Differences in bone turnover marker carboxy-terminal collagen crosslinks	Differences in bone turnover marker carboxy-terminal collagen crosslinks (ng/L)	Study day 1 versus study day 2
Primary	Changes in glucose variability	Changes in glucose variability measured by a continuous glucose monitor	2 weeks versus 2 weeks
Secondary	Changes in plasma insulin	insulin (pmol/L)	Study day 1 versus study day 2
Secondary	Changes in plasma glucagon	glucagon (ng/L)	Study day 1 versus study day 2
Secondary	Changes in nitrogen balance	Changes in nitrogen balance by comparing output (feces/urine) versus intake (oral/enteral/parenteral)	Study day 1 versus study day 2
Secondary	Changes in sleep/wake rhythm	Changes in sleep/wake rhythm measured by an actigraph	2 weeks versus 2 weeks
Secondary	Changes in sleep quality	Changes in sleep quality, measured by Visual Analogue Scale (VAS) score (scale 1-10, higher scores mean better outcome)	2 weeks versus 2 weeks
Secondary	Changes in clock gene expression	Changes in clock gene expression in leukocytes (if feasible; pilot)	Study day 1 versus study day 2
Secondary	Changes in energy expenditure	Changes in energy expenditure assessed by indirect calorimetry (kcal/24h)	Study day 1 versus study day 2
Secondary	Changes in substrate oxidation rates	Changes in substrate oxidation rates assessed by indirect calorimetry (percent)	Study day 1 versus study day 2