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

History of Changes

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:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis Liver Diseases Liver Transplantation

U.S. FDA Resources

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:

Montejo González JC, Mesejo A, Bonet Saris A; Metabolism and Nutrition Working Group of the Spanish Society of Intensive Care Medicine and Coronary units. Guidelines for specialized nutritional and metabolic support in the critically-ill patient: update. Consensus SEMICYUC-SENPE: liver failure and liver transplantation. Nutr Hosp. 2011 Nov;26 Suppl 2:27-31. doi: 10.1590/S0212-16112011000800006. Review.

Lee WG, McCall JL, Gane EJ, Murphy R, Plank LD. Oral β-blockade in relation to energy expenditure in clinically stable patients with liver cirrhosis: a double-blind randomized cross-over trial. Metabolism. 2012 Nov;61(11):1547-53. doi: 10.1016/j.metabol.2012.04.001. Epub 2012 May 4.

Anastácio LR, Ferreira LG, Ribeiro Hde S, Lima AS, Vilela EG, Correia MI. Weight loss during cirrhosis is related to the etiology of liver disease. Arq Gastroenterol. 2012 Jul-Sep;49(3):195-8.

Ferreira LG, Anastácio LR, Correia MI. The impact of nutrition on cirrhotic patients awaiting liver transplantation. Curr Opin Clin Nutr Metab Care. 2010 Sep;13(5):554-61. doi: 10.1097/MCO.0b013e32833b64d2. Review.


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 Diseases Digestive System Diseases

ClinicalTrials.gov processed this record on February 26, 2015

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