Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000024246
Ethics application status
Approved
Date submitted
22/12/2017
Date registered
12/01/2018
Date last updated
12/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Total body protein and sarcopenia in patients with liver cirrhosis
Scientific title
Relationship between total body protein and cross-sectional skeletal muscle area in liver cirrhosis
Secondary ID [1] 293669 0
None
Universal Trial Number (UTN)
U1111-1206-9534
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cirrhosis 305960 0
malnutrition 305961 0
sarcopenia 305962 0
Condition category
Condition code
Oral and Gastrointestinal 305158 305158 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Diet and Nutrition 305263 305263 0 0
Other diet and nutrition disorders
Musculoskeletal 305264 305264 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All participants retrospectively identified will have undergone in vitro neutron activation analysis (IVNAA) and dual energy x-ray absorptiometry (DXA) measurements of total body protein as part of previous body composition research studies. Clinical medical records will be evaluated to identify individuals who have undergone routine clinical abdominal computed tomography (CT) and/or magnetic resonance imaging (MRI) scans within 30 days of IVNAA measurement.
Intervention code [1] 299928 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304307 0
The primary outcome for this study is the relationship between total body protein (gold-standard measurements by IVNAA), and cross-sectional skeletal muscle area as identified from abdominal imaging (CT and/or MRI scan).
Timepoint [1] 304307 0
Cross sectional abdominal imaging (CT or MRI) performed within 30 days of IVNAA measurement.
Secondary outcome [1] 341550 0
To determine the effect of hydration status (determined by total body water, derived from IVNAA and DXA measurements), on the relationship between total body protein (assessed by IVNAA) and cross-sectional skeletal muscle area (assessed from CT/MRI abdominal imaging).
Timepoint [1] 341550 0
Cross sectional abdominal imaging (CT or MRI) performed within 30 days of IVNAA measurement.

Eligibility
Key inclusion criteria
1. Patients with a clinical diagnosis of chronic liver disease/cirrhosis who have previously been participants in body composition studies conducted by the Body Composition Unit at Auckland University.
2. Undergone total body protein measurements by IVNAA as part of these prior research studies.
3. Undergone CT/MRI abdominal imaging for routine clinical reasons within 30 days of IVNAA.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with acute hospital admissions, surgical procedures (including abdominal paracentesis), or other significant clinical events (major bleeding, encephalopathy, or sepsis) during the interval between IVNAA and abdominal imaging
2. Patients with cross-sectional imaging not including the third lumbar vertebral body.
3. Data obtained following liver transplantation.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
No sample-size calculations will be performed.

Linear regression using Pearson's correlation coefficient will be performed to examine the bivariate association between total body protein and skeletal muscle area. Sensitivity and specificity for previously-published cross-sectional muscle area cutoffs will be calculated for their association with total body protein depletion. Analysis of covariance (ANCOVA) will be used to adjust the means for TBP for comparison of SMA between normally hydrated and over-hydrated groups. To further assess the impact of over-hydration on SMA, a multiple linear regression model will be constructed using TBP and hydration index as independent variables, and SMA as the dependent variable.

Bland-Altman plots will be constructed for patients with both CT and MRI measurements of cross-sectional muscle area within a 30-day interval to assess agreement between these two modalities.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/03/2016
Date of last participant enrolment
Anticipated
Actual
6/03/2017
Date of last data collection
Anticipated
Actual
6/03/2017
Sample size
Target
100
Accrual to date
Final
107
Recruitment outside Australia
Country [1] 9461 0
New Zealand
State/province [1] 9461 0
Auckland

Funding & Sponsors
Funding source category [1] 298289 0
Charities/Societies/Foundations
Name [1] 298289 0
Maurice and Phyllis Paykel Trust
Country [1] 298289 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Department of Surgery
Auckland City Hospital Support Building
2 Park Road
Grafton
Auckland 1023
New Zealand
Country
New Zealand
Secondary sponsor category [1] 297404 0
None
Name [1] 297404 0
Address [1] 297404 0
Country [1] 297404 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299288 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 299288 0
The University of Auckland
Private Bag 92019
Auckland 1142, New Zealand
Ethics committee country [1] 299288 0
New Zealand
Date submitted for ethics approval [1] 299288 0
22/06/2015
Approval date [1] 299288 0
10/08/2015
Ethics approval number [1] 299288 0
UAHPEC 015477

Summary
Brief summary
Protein calorie malnutrition is common in patients with chronic liver disease/cirrhosis. Sarcopenia (reduced muscle mass) has been shown to be an independent predictor of mortality and morbidity in a wide range of conditions, including on the liver transplant waiting list, and also following transplantation. The cross-sectional area skeletal muscle on CT or MRI is a simple and widely available measurement that has previously been used as a measure of sarcopenia. However, it has not been validated against the gold standard method of TBP measured using in vivo neutron activation analysis (IVNAA).

This study will compare two different ways of measuring body protein stores; cross sectional skeletal muscle area on CT or MRI will be compared to the gold standard method of in-vivo neutron activation analysis (IVNAA). Patients undergoing major abdominal surgery and chronic liver disease patients, who have previously been participants in studies conducted by the Body Composition Unit will be assessed for inclusion in the study. Individuals who have had both cross sectional imaging with CT or MRI and IVNAA within one month of each other will be identified retrospectively from laboratory and radiology records. No new measurement or prospective recruitment will be undertaken.

We aim to validate the use of cross sectional skeletal muscle area as a measure of TBP in patients with chronic liver diease. This is relevant to future clinical and research studies that rely in this cross sectional imaging to measure sarcopenia in these patient populations.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79922 0
A/Prof Lindsay Plank
Address 79922 0
Department of Surgery
University of Auckland,
Private Bag 92019,
Auckland 1142,
New Zealand
Country 79922 0
New Zealand
Phone 79922 0
+64-9-923-6949
Fax 79922 0
Email 79922 0
[email protected]
Contact person for public queries
Name 79923 0
A/Prof Lindsay Plank
Address 79923 0
Department of Surgery
University of Auckland,
Private Bag 92019,
Auckland 1142,
New Zealand
Country 79923 0
New Zealand
Phone 79923 0
+64-9-923-6949
Fax 79923 0
Email 79923 0
[email protected]
Contact person for scientific queries
Name 79924 0
A/Prof Lindsay Plank
Address 79924 0
Department of Surgery
University of Auckland,
Private Bag 92019,
Auckland 1142,
New Zealand
Country 79924 0
New Zealand
Phone 79924 0
+64-9-923-6949
Fax 79924 0
Email 79924 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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