Assessment of Nutritional Status of Patients With Liver Cirrhosis

NCT03242798 | Completed

• 1 other identifier: 105
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cirrhosis; Malnutrition

Keywords

liver cirrhosis; malnutrition; nutritional status; nutritional assessment

Outcome Measures

Primary Outcomes (1)

• Prevalence of malnutrition phenotypes.

  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 Outcomes (3)

• Survival.

  One year after baseline measurements

• Validity test of available tools.

  Baseline

• Nutritional status after medical treatment according to the etiology of cirrhosis.

  6 months after baseline measurements

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adults with biopsy proven cirrhosis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harokopio University: lead
• Laikο General Hospital, Athens: collaborator

Study Sites (1)

Harokopio University

Kallithea, Attica, 17671, Greece

Location

MeSH Terms

Conditions

Fibrosis; Malnutrition; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Liver Diseases; Digestive System Diseases

Study Officials

• Meropi D. Kontogianni, PhD

  Harokopio University

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 8, 2017
• Study Start: March 3, 2016
• Primary Completion: October 1, 2018
• Study Completion: March 1, 2020
• Last Updated: August 30, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)