Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05868785
Status:
RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-04-21
Brief Title:
Effect of Nocturnal Parenteral Nutrition on Bone Turnover and Energy Metabolism
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
The Effect of Parenteral Nutrition During Nighttime Versus Daytime on Bone Turnover and Energy Metabolism in Intestinal Failure Patients
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NutriSync
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None