search
Back to results

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

Primary Purpose

Intestinal Failure, Osteoporosis, Insulin Sensitivity

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Parenteral nutrition
Parenteral nutrition
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Intestinal Failure focused on measuring Parenteral Nutrition, Intestinal Failure, Circadian misalignment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Amsterdam University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Nocturnal parenteral nutrition

Diurnal parenteral nutrition

Arm Description

Patients will receive nocturnal parenteral nutrition, starting at 8pm

Patients will receive diurnal parenteral nutrition, starting at 8am

Outcomes

Primary Outcome Measures

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)
Differences in bone turnover marker carboxy-terminal collagen crosslinks
Differences in bone turnover marker carboxy-terminal collagen crosslinks (ng/L)
Changes in glucose variability
Changes in glucose variability measured by a continuous glucose monitor

Secondary Outcome Measures

Changes in plasma insulin
insulin (pmol/L)
Changes in plasma glucagon
glucagon (ng/L)
Changes in nitrogen balance
Changes in nitrogen balance by comparing output (feces/urine) versus intake (oral/enteral/parenteral)
Changes in sleep/wake rhythm
Changes in sleep/wake rhythm measured by an actigraph
Changes in sleep quality
Changes in sleep quality, measured by Visual Analogue Scale (VAS) score (scale 1-10, higher scores mean better outcome)
Changes in clock gene expression
Changes in clock gene expression in leukocytes (if feasible; pilot)
Changes in energy expenditure
Changes in energy expenditure assessed by indirect calorimetry (kcal/24h)
Changes in substrate oxidation rates
Changes in substrate oxidation rates assessed by indirect calorimetry (percent)

Full Information

First Posted
April 21, 2023
Last Updated
October 20, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Netherlands Organisation for Scientific Research
search

1. Study Identification

Unique Protocol Identification Number
NCT05868785
Brief Title
Effect of Nocturnal Parenteral Nutrition on Bone Turnover and Energy Metabolism
Acronym
NutriSync
Official Title
The Effect of Parenteral Nutrition During Nighttime Versus Daytime on Bone Turnover and Energy Metabolism in Intestinal Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2023 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Netherlands Organisation for Scientific Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Failure, Osteoporosis, Insulin Sensitivity
Keywords
Parenteral Nutrition, Intestinal Failure, Circadian misalignment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized crossover pilot study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nocturnal parenteral nutrition
Arm Type
Active Comparator
Arm Description
Patients will receive nocturnal parenteral nutrition, starting at 8pm
Arm Title
Diurnal parenteral nutrition
Arm Type
Experimental
Arm Description
Patients will receive diurnal parenteral nutrition, starting at 8am
Intervention Type
Dietary Supplement
Intervention Name(s)
Parenteral nutrition
Other Intervention Name(s)
active comparator
Intervention Description
Parenteral nutrition will be administered starting at 8 pm
Intervention Type
Dietary Supplement
Intervention Name(s)
Parenteral nutrition
Other Intervention Name(s)
experimental
Intervention Description
Parenteral nutrition will be administered starting at 8 am
Primary Outcome Measure Information:
Title
Differences in bone turnover marker Procollagen 1 Intact N-Terminal Propeptide
Description
Differences in the bone turnover marker Procollagen 1 Intact N-Terminal Propeptide (ug/L)
Time Frame
Study day 1 versus study day 2
Title
Differences in bone turnover marker carboxy-terminal collagen crosslinks
Description
Differences in bone turnover marker carboxy-terminal collagen crosslinks (ng/L)
Time Frame
Study day 1 versus study day 2
Title
Changes in glucose variability
Description
Changes in glucose variability measured by a continuous glucose monitor
Time Frame
2 weeks versus 2 weeks
Secondary Outcome Measure Information:
Title
Changes in plasma insulin
Description
insulin (pmol/L)
Time Frame
Study day 1 versus study day 2
Title
Changes in plasma glucagon
Description
glucagon (ng/L)
Time Frame
Study day 1 versus study day 2
Title
Changes in nitrogen balance
Description
Changes in nitrogen balance by comparing output (feces/urine) versus intake (oral/enteral/parenteral)
Time Frame
Study day 1 versus study day 2
Title
Changes in sleep/wake rhythm
Description
Changes in sleep/wake rhythm measured by an actigraph
Time Frame
2 weeks versus 2 weeks
Title
Changes in sleep quality
Description
Changes in sleep quality, measured by Visual Analogue Scale (VAS) score (scale 1-10, higher scores mean better outcome)
Time Frame
2 weeks versus 2 weeks
Title
Changes in clock gene expression
Description
Changes in clock gene expression in leukocytes (if feasible; pilot)
Time Frame
Study day 1 versus study day 2
Title
Changes in energy expenditure
Description
Changes in energy expenditure assessed by indirect calorimetry (kcal/24h)
Time Frame
Study day 1 versus study day 2
Title
Changes in substrate oxidation rates
Description
Changes in substrate oxidation rates assessed by indirect calorimetry (percent)
Time Frame
Study day 1 versus study day 2
Other Pre-specified Outcome Measures:
Title
Changes in body temperature
Description
Changes in body temperature measured by i-buttons (Celsius)
Time Frame
Study day 1 versus study day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
M.J.M. Serlie, professor
Phone
+31205669111
Email
m.j.m.serlie@amsterdamumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
P.H.L.T. Bisschop, professor
Phone
+31205669111
Email
p.h.bissschop@amsterdamumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G.M. vd Werf, MSc, RD
Organizational Affiliation
Amsterdam UMC, location AMC
Official's Role
Study Director
Facility Information:
Facility Name
Amsterdam University Medical Center
City
Amsterdam
State/Province
North Holland
ZIP/Postal Code
1105AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GM van der Werf, MSc
Phone
+31205665120
Email
g.m.vanderwerf@amsterdamumc.nl
First Name & Middle Initial & Last Name & Degree
M.J. Serlie, prof
Phone
+31205666071
Email
m.j.serlie@amsterdamumc.nl

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Non-identifiable data will be available after signing a data sharing agreement with the legal support office of the Amsterdam University Medical Center
IPD Sharing Time Frame
After publication of the study results and for a period of 15 years
IPD Sharing Access Criteria
Data sharing agreement with legal support office

Learn more about this trial

Effect of Nocturnal Parenteral Nutrition on Bone Turnover and Energy Metabolism

We'll reach out to this number within 24 hrs