Assessment of Nutritional Status of Patients With Liver Cirrhosis

August 27, 2022 updated by: Meropi Kontogianni, Harokopio University
Cirrhosis is the twelfth leading cause of death worldwide. Malnutrition is prevalent among cirrhotic patients and is an important prognostic factor. Nutritional assessment is therefore crucial for identifying patients at risk or with already established malnutrition and refer them for nutritional intervention and support. In the current literature, nutritional assessment of cirrhotic patients is performed using several tools and methods. However their accuracy is widely affected by the underline disease and its complications. In addition, for the majority of the parameters under study, no gold standard tools and methods have been established so far. Studies on nutritional assessment in cirrhosis usually focus on one or few aspects of nutritional status and not on a full nutritional assessment combining information from medical, biochemical, nutritional, and body composition variables. Hence, the present study aims at a thorough assessment of the nutritional status of 170 cirrhotic patients using multiple widely available tools and methods, in order to assess their accuracy and estimate the prevalence of multiple malnutrition phenotypes such as undernutrition, sarcopenia, sarcopenic obesity and cachexia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The study sample will comprise of 170 adults with biopsy proven cirrhosis. A detailed medical and nutritional assessment will be implemented at baseline. For patients that will receive an intervention aiming at the cause of cirrhosis (e.g. antivirus therapy for HCV or HBV) the baseline assessment will take place before the beginning of the therapy and will be repeated three months after the completion of the medical intervention to explore the impact of the intervention on nutritional status. Data regarding the survival of all the patients will be collected one year after the baseline assessment.

More specifically regarding the detailed assessment, firstly, hepatologists of the research team will complete a full medical record regarding the primary disease, cirrhosis' complications, comorbidities and medication. The severity of cirrhosis will be assessed using the Child-Pugh score. Furthermore, in the Laboratory of Clinical Nutrition & Dietetics at Harokopio University, patients will participate in the following procedures:

  • Anthropometry: Weight, height, waist and mid-arm circumference, and triceps skinfold will be measured. Body mass index, mid-arm muscle circumference and area will be estimated using standard equations.
  • Body composition analysis: Total body DXA (Lunar DPX-MD, Madison, WI, USA) will be performed.
  • Muscle strength and performance status: Handgrip strength measurement based on certain protocol and the "Short Physical Performance Battery" tool will be implemented.
  • Dietary intake evaluation: Three non-consecutive 24h recalls (two weekdays and one weekend day) will be recorded. Data will be analyzed to estimate energy, macro- and micronutrients intake (Nutritionist Pro software, 2.2 version). Food group intake and meal patterns will also be evaluated.
  • Physical activity assessment: Patients' physical activity levels will be assessed using the "Harokopio Physical Activity Questionnaire".

For patients with available upper abdomen computed tomographies skeletal muscle index at L3 will be calculated with the software SliceOmatic V5.0 software, Tomovision, Montreal, PQ. In addition, patients' nutritional risk or nutritional status will be assessed through several previously validated tools like the Subjective Global Assessment, the Royal Free Hospital Global assessment scheme and Liver Disease Undernutrition Screening Tool, the efficacy of which will be tested in the present study. Patients will be also categorized according to ESPEN's recent malnutrition diagnostic criteria.

The full assessment will be repeated only for patients who will receive an intervention aiming at the cause of cirrhosis (e.g. antivirus therapy for HCV or HBV) three months after the completion of the medical intervention.

One year after the baseline assessment of the study samples, data will be collected regarding survival, development of complications and decompensated cirrhosis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
201

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

  • Greece
    • Attiki
      • Kallithea, Attiki, Greece, 17671
        • Harokopio University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study sample will comprise of 170 adults with biopsy proven cirrhosis visiting hospital Liver Outpatient Clinics in Athens, Greece.

Description

Inclusion Criteria:

Adults with biopsy proven cirrhosis.

Exclusion Criteria:

Patients with hepatocellular carcinoma, in hepatic coma, with acquired immunodeficiency syndrome, with renal or pancreatic insufficiency, receiving enteral nutrition or being pregnant, will be excluded.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prevalence of malnutrition phenotypes.
Time Frame: Baseline
Prevalence of different malnutrition phenotypes (e.g. undernutrition, sarcopenia, sarcopenic obesity), in cirrhotic patients of different disease stages, by implementing a thorough nutritional assessment.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Survival.
Time Frame: One year after baseline measurements
Assessment of survival one year after baseline measurements and association with the malnutrition phenotypes at baseline.
One year after baseline measurements
Validity test of available tools.
Time Frame: Baseline
Test the sensitivity, specificity, positive and negative prognostic values of already available tools for nutritional screening or assessment against a combined index as the reference tool. If no tool is estimated as valid, a new combination of nutritional, biochemical and/or clinical parameters will be synthesized and its validity as a new screening or assessment tool will be assessed for the detection of cirrhotic patients at risk of malnutrition or already malnourished.
Baseline
Nutritional status after medical treatment according to the etiology of cirrhosis.
Time Frame: 6 months after baseline measurements
Changes in the nutritional status after medical treatment according to the etiology of cirrhosis, namely antivirus therapy for HCV or HBV cirrhosis, abstinence from alcohol in the alcoholic cirrhosis, immunosuppressive therapy in autoimmune cirrhosis.
6 months after baseline measurements

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Harokopio University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Laikο General Hospital, Athens

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Meropi D. Kontogianni, PhD, Harokopio University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 3, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be available upon demand.

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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