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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01761851
First Posted: January 7, 2013
Last Update Posted: January 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais
  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 Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais:

Primary Outcome Measures:
  • Resting energy expenditure [ Time Frame: 12 months ]
    Assess resting energy expenditure


Secondary Outcome Measures:
  • Metabolic alterations - hyper or hypo metabolism [ Time Frame: 12 months ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( Other Grant/Funding Number: Fapemig CDS - APQ-04415-10 )
First Submitted: January 3, 2013
First Posted: January 7, 2013
Last Update Posted: January 7, 2013
Last Verified: January 2013

Keywords provided by Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais:
Resting metabolic rate
nutrition status
dietary intake

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases