NCT05868785

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 13, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

1.3 years

First QC Date

April 21, 2023

Last Update Submit

October 20, 2023

Conditions

Intestinal FailureOsteoporosisInsulin Sensitivity

Keywords

Parenteral NutritionIntestinal FailureCircadian misalignment

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Changes in glucose variability

    Changes in glucose variability measured by a continuous glucose monitor

    2 weeks versus 2 weeks

Secondary Outcomes (8)

  • Changes in plasma insulin

    Study day 1 versus study day 2

  • Changes in plasma glucagon

    Study day 1 versus study day 2

  • Changes in nitrogen balance

    Study day 1 versus study day 2

  • Changes in sleep/wake rhythm

    2 weeks versus 2 weeks

  • Changes in sleep quality

    2 weeks versus 2 weeks

  • +3 more secondary outcomes

Other Outcomes (1)

  • Changes in body temperature

    Study day 1 versus study day 2

Study Arms (2)

Nocturnal parenteral nutrition

ACTIVE COMPARATOR

Patients will receive nocturnal parenteral nutrition, starting at 8pm

Dietary Supplement: Parenteral nutrition

Diurnal parenteral nutrition

EXPERIMENTAL

Patients will receive diurnal parenteral nutrition, starting at 8am

Dietary Supplement: Parenteral nutrition

Interventions

Parenteral nutritionDIETARY_SUPPLEMENT

Parenteral nutrition will be administered starting at 8 pm

Also known as: active comparator
Nocturnal parenteral nutrition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Home parenteral nutrition for at least 5 nights a week
  • On home parenteral nutrition for more than 1 year

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam University Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Intestinal FailureOsteoporosisInsulin ResistanceHyperphagia

Interventions

Parenteral Nutrition

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinismGlucose Metabolism DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • G.M. vd Werf, MSc, RD

    Amsterdam UMC, location AMC

    STUDY DIRECTOR

Central Study Contacts

M.J.M. Serlie, professor

CONTACT

+31205669111m.j.m.serlie@amsterdamumc.nl

P.H.L.T. Bisschop, professor

CONTACT

+31205669111p.h.bissschop@amsterdamumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Randomized crossover pilot study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr.

Study Record Dates

First Submitted

April 21, 2023

First Posted

May 22, 2023

Study Start

July 13, 2023

Primary Completion

November 1, 2024

Study Completion

November 1, 2025

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

Non-identifiable data will be available after signing a data sharing agreement with the legal support office of the Amsterdam University Medical Center

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After publication of the study results and for a period of 15 years
Access Criteria
Data sharing agreement with legal support office

Locations

NL(1)