Resting Energy Expenditure in Patients on the Waiting List for Liver Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT01761851
First received: January 3, 2013
Last updated: January 4, 2013
Last verified: January 2013
  Purpose

Metabolic disorders and malnutrition are well known and have been reported in patients with chronic liver disease, but the relationship of energy metabolism and changes in nutritional status in patients on the waiting list for liver transplantation are unexplored. The aim of this study was to assess the resting energy expenditure (REE) of these patients, identifying the prevalence of hyper and hypometabolism. In addition, to assess if, malnutrition and clinical variables were associated with REE and metabolic disorders.


Condition
Liver Disease
Cirrhosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Metabolic and Nutritional Assessment in Patients on the Waiting List for Liver Transplantation

Resource links provided by NLM:


Further study details as provided by Federal University of Minas Gerais:

Primary Outcome Measures:
  • Resting energy expenditure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assess resting energy expenditure


Secondary Outcome Measures:
  • Metabolic alterations - hyper or hypo metabolism [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assess the metabolic status of the patients


Enrollment: 80
Study Start Date: March 2010
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cases
Liver cirrhosis

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients on the waiting list for liver transplant

Criteria

Inclusion Criteria:

  • all patients who agreed to participate and signed the informed consent

Exclusion Criteria:

  • those who refused to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01761851

Locations
Brazil
Ambulatório de Transplantes Hepáticos
Belo Horizonte, MG, Brazil
Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
Principal Investigator: Maria Isabel TD Correia, MD, PhD Federal University of Minas Gerais
  More Information

Publications:
Responsible Party: Maria Isabel Toulson Davisson Correia, Principal investigator, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT01761851     History of Changes
Other Study ID Numbers: CDS - APQ-04415-10, CDS - APQ-04415-10
Study First Received: January 3, 2013
Last Updated: January 4, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of Minas Gerais:
Resting metabolic rate
nutrition status
dietary intake

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 18, 2014