- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04223453
Body Composition Measurements in Pneumonia
January 8, 2020 updated by: Jens Rikardt Andersen
Body Composition in Patients With Acute Pneumonia Measured by Bioimpedance and DXA
The purpose of this study is to validate and standardize bioelectrical impedance analysis (BIA, Maltron BioScan touch i8) for estimating body composition in hospitalized elderly patients with pneumonia.
Body composition assessments with BIA and dual-energy x-ray absorptiometry (DXA,
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Holigic Discovery) was performed on 36 non-fasting patients over 65 years of age.
29 patients had BIA performed within 24 hours after hospital admission and at the date of discharge.
17 patients had BIA performed in fasted state and one hour after an intake of 300 ml glucose solution.
Study Type
Observational
Enrollment (Actual)
36
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hillerød, Denmark, 3400
- Hillerød Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
X-ray verified acute pneumonia > 65 years of age
Description
Inclusion Criteria:
- Acute pneumonia,
- Accept participation (informed consent)
- Understand the given instructions and information
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between LBM (lean body mass) with DXA and BIA
Time Frame: within 3 days
|
At admittance both methods.
|
within 3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Development in lean-body-mass during hospital stay
Time Frame: 3-10 days (hospital stay)
|
Repeated measurement with BIA during the state of acute infection
|
3-10 days (hospital stay)
|
BIA measured before and after oral glucose load test
Time Frame: 1 hour
|
To investigate for the effect of fasting on the determination of total body water with BIA
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jens R Andersen, MD,MPA, University of Copenhagen, Department of Nutrition, Exercise and Sports
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 5, 2019
Primary Completion (Actual)
July 17, 2019
Study Completion (Actual)
September 30, 2019
Study Registration Dates
First Submitted
January 7, 2020
First Submitted That Met QC Criteria
January 8, 2020
First Posted (Actual)
January 10, 2020
Study Record Updates
Last Update Posted (Actual)
January 10, 2020
Last Update Submitted That Met QC Criteria
January 8, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Daniel1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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