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

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ClinicalTrials.gov Identifier: NCT01761851
Recruitment Status : Completed
First Posted : January 7, 2013
Last Update Posted : January 7, 2013
Sponsor:
Information provided by (Responsible Party):
Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease
Liver Disease Cirrhosis

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Study Design
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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Metabolic and Nutritional Assessment in Patients on the Waiting List for Liver Transplantation
Study Start Date : March 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : December 2011

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Groups and Cohorts
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Group/Cohort
Cases
Liver cirrhosis


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Secondary Outcome Measures :
  1. Metabolic alterations - hyper or hypo metabolism [ Time Frame: 12 months ]
    Assess the metabolic status of the patients


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: January 7, 2013    Key Record Dates
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