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CompletedNCT01761851Updated Jan 7, 2013

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

An observational study in Liver Disease and Cirrhosis, sponsored by Federal University of Minas Gerais. Completed at 1 site in Brazil. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-01-07.

Sponsored by Federal University of Minas Gerais · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

This cross-sectional and descriptive study was carried out at the Alfa Institute of Gastroenterology, Hospital of Clinics, Universidade Federal of Minas Gerais (UFMG). The research protocol was approved by the UFMG Ethics Committee. Patients with indication for liver transplantation, aged over 20 years who regularly attended the Liver Outpatient Transplant Clinic were included after having agreed and signed the informed consent form. The presence of endocrine abnormalities (hyper/hypothyroidism) and patients on the waiting list for a double or re-transplant were excluding conditions. The REE and nutritional status assessment were performed by the same trained investigator (LGF) in order to reduce errors.

Resting Energy Expenditure - REE was measured by indirect calorimetry using a gas analyzer K4b2 (Cosmed, Rome, Italy). The test was performed in a silent, temperature-controlled room (22-24oC) in the morning, between 08:00am and 09:30am. The patients fasted for 12 hours, and remained on the lying position for about 20 minutes before the beginning of the test. The device was calibrated before each exam. The volume of inspired oxygen (VO2) and exhaled carbon dioxide (VCO2) was collected through a turbine and a sample line, adapted to the face mask, applied to the patient and, connected to the unit. The collection of gases occurred for 25 minutes, and the first 5 minutes were discarded. The mean VO2 and VCO2 per minute were used to calculate the REE according to the Weir formula. The obtained data were multiplied by 1,440 to obtain the 24-hour REE. Therefore, the REE was divided by kilograms of fat free mass - FFM (REE/FFM). Predicted REE was calculated from the Harris and Benedict formula (REEHB). In patients with fluid retention (clinical evidence of ascites and/or limb edema) dry weight was calculated by deducting an estimated weight for ascites and/or limb edema. Hypermetabolic patients were identified if the ratio REE:REEHB was > 120% and hypometabolic patients were classified according to the ratio REE:REEHB \< 80%. The non-protein respiratory quotient (RQ) was calculated by the formula VCO2/VO2. Oxidation rates of carbohydrate and fat were expressed as percentages of total generated energy.

Nutritional Assessment - Nutritional status was provided by the Subjective Global Assessment (SGA), anthropometric measurements, handgrip strength, bioimpedance and energy balance (EB) analyses. The SGA adapted for patients on the waiting list for liver transplantation is based on clinical history and physical examination, as well as the presence of existing conditions such as encephalopathy, chronic or recurrent infection, varicose veins and renal function. Patients were classified as nourished and those classified as suspected or moderately malnourished and severely malnourished were grouped together to form the malnourished group.

Anthropometric evaluation was comprised of weight, height, body mass index (BMI), triceps and subscapular skinfold thickness (TSF and SSF respectively, measured with the Lange Skinfold Caliper - Cambridge Scientific Industries Inc., Cambridge, MD, USA), midarm circumference (MAC, measured with inextensible tape), arm muscle area (AMA) and arm fat area (AFA). To minimize practical variability, the average of three consecutive measurements was recorded. Values of TSF, SSF, MAC, AMA and AFA below the 5th percentile and BMI below 18.5kg/m2 (or 22.0kg/m2 for elderly) were considered as malnutrition.

Handgrip strength (HS) was assessed with the Jamar Handgrip Dynamometer (Preston, Jackson, MI, USA) using the non-dominant arm, and the mean of three measurements was determined. Malnutrition was defined as values of HS below the 5th percentile.

Bioelectrical impedance analysis (Quantum X - RJL Systems, Inc., Clinton Township, Michigan) was used to determine body composition. Measurements were made with patients lying in bed with 4 electrodes attached to the dorsum of the right hand and foot. Phase angle (PA), fat mass (FM - kg), fat free mass (FFM, kg), total body water (TBW - L), intracellular water (ICW - L) and extracellular water (ECW - L), were evaluated. PA was categorized in equal to or less than 5.4o, or above 5.4o as proposed by Selberg et al.

The energy balance (EB) was obtained by subtracting the total energy expenditure from the total caloric intake (TCI). The TEE was obtained by multiplying the 24-hour REE by the calculated activity factor (AF), which was based on the description of the patients' daily activities and the corresponding computed values of metabolic equivalents (METs). Food intake was assessed by a 3-day food record (DietPro5i® Agromídia Software, Viçosa, Brazil).

Clinical and other variables - Age, sex, etiology, severity of liver disease by the Child-Pugh score (22) and the Model for End Stage Liver Disease score (MELD), complications like presence of fluid retention and hepatic encephalopathy; number of medication and diuretics; β-blockers and lactulose use were all compiled. Diagnosis of liver cirrhosis was based of clinical, biochemical and histopathological data. The indications for liver transplantation were categorized into alcoholic cirrhosis, viral and other diseases. Liver function tests (aspartate aminotransferase - AST, alanine aminotransferase- ALT, total bilirubin-TB and international normalized ratio-INR), presence of diabetes and/or glucose intolerance (24) and fasting glucose were also investigated.

02

Conditions studied

  • Liver Disease
  • Cirrhosis

Keywords

  • Resting metabolic rate
  • nutrition status
  • dietary intake
03

In context

Liver Diseases

2,094 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 80 is below the median of 165 across 689 observational studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Federal University of Minas Gerais is the lead sponsor of 152 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients on the waiting list for liver transplant

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • those who refused to participate
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • Cases

    Liver cirrhosis

06

What researchers measure

Primary outcomes

  1. Resting energy expenditure

    Assess resting energy expenditure

    Time frame: 12 months

Secondary outcomes

  1. Metabolic alterations - hyper or hypo metabolism

    Assess the metabolic status of the patients

    Time frame: 12 months

07

Study locations

1 site
  • Ambulatório de Transplantes Hepáticos
    Belo Horizonte, Minas Gerais, Brazil
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References and documents

Publications

  • Montejo Gonzalez 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. PubMed 22411515 ↗
  • Lee WG, McCall JL, Gane EJ, Murphy R, Plank LD. Oral beta-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. PubMed 22560128 ↗
  • Anastacio 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. doi: 10.1590/s0004-28032012000300005. PubMed 23011241 ↗
  • Ferreira LG, Anastacio 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. PubMed 20531175 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01761851
Responsible party
Maria Isabel Toulson Davisson Correia (Principal investigator, Federal University of Minas Gerais) — Principal investigator
First posted
Jan 7, 2013
Start date
Mar 2010
Primary completion
Jun 2011
Completion
Dec 2011
Last update
Jan 7, 2013

Study contacts

Maria Isabel TD Correia, MD, PhD
principal investigator · Federal University of Minas Gerais

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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