NCT06946537

Brief Summary

Disease-related malnutrition (DRM) describes undernutrition or imbalances in energy, protein, or other nutrient-needs, caused by a concomitant disease. Nutritional status plays a vital role in the fate of hospitalized patients, and DRM is associated with loss of function and decreased survival. DRM is a common condition in patients with acute illnesses, approximately 30% among medical inpatients are malnourished when admitteed to the hospital, and rise higher among the older or critically ill. Physiologically malnutrition is associated with a) poorer tissue healing and restitution after severe disease, b) suppressed immune function and resistance towards infections, c) poorer metabolic defense towards critical disease, d) delayed and poorer progress of chronic diseases. In addition, inadequate nutrition is coupled to a prolonged hospital stay, resulting in more readmissions, and overall higher mortality in hospital patients. Yet, nutritional status of patients upon hospital admittance is seldom systematically assessed and the consequences of DRM in older acutely admitted patients still needs to be understood. This project will provide a detailed description of nutritional, physiolgical, and biochemical status of 1500 acutely admitted patients. In relation, the study will investigate the relation between patient characteristics and disease progression. The obtained data will also be coupled to patient registers to investigate the link between length of hospital stay, readmissions and acute contact, and mortality.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
30mo left

Started May 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress29%
May 2025Nov 2028

First Submitted

Initial submission to the registry

April 25, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

May 12, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

1.9 years

First QC Date

April 25, 2025

Last Update Submit

May 12, 2025

Conditions

Keywords

GeriatricDisease-related malnutritionPhysiologyAcute illnessDeep phenotypingNutritional status

Outcome Measures

Primary Outcomes (1)

  • Length of Hospital Stay

    Time (in hours) hospitalized from arrival to discharge

    From date of hospital admission untill discharge, assessed up to 2 months

Secondary Outcomes (3)

  • Readmission

    Time to readmission 30 days from discharge

  • Acute contact

    Time to acute contact 30 days from discharge

  • Mortality

    Time to mortality 90 days from index admission

Study Arms (1)

The INSIGHT cohort

A geriatric cohort (age ≥ 65) established to investigate the coupling of phenotypical characteristics to nutritional and physiological status. The study intent to explore whether Disease-Related Malnutrition provides predictive value for patient prognosis based on specific phenotypic characteristics and establish different physiological stratifications to improve the identification of acutely admitted patients.

Other: Exposures and measurements

Interventions

Anthropometry, Body composition (BIA), Nutritional screening (GLIM, SNAQ, NIS, NRS-2002), Functional tests, Seisomocardiography, Muscle strength, Blood tests, Fecal swabs, Indirect calorimetry Orientation-Memory-Concentration (OMC), Sarcopenia, Frailty (Clinical Frailty Scale), Comobidity, Polypharmacy, Portrait photo.

The INSIGHT cohort

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients acutely admitted at Bispebjerg Hospital

You may qualify if:

  • Acutely admitted adults aged 65 years and above.
  • Be able to comply with the study information, as assessed by the research personnel.
  • Be able to understand Danish.

You may not qualify if:

  • \<24 hours admission
  • Terminal illness in end stage of life
  • Patients with temporary civil person registration number (CPR)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, 2400, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood (plasma and serum) and feces (fecal swabs)

MeSH Terms

Conditions

Malnutrition

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 25, 2025

First Posted

April 27, 2025

Study Start

May 12, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

November 1, 2028

Last Updated

May 14, 2025

Record last verified: 2025-05

Locations