Liver DiseaseNCT01761851
Resting Energy Expenditure in Patients on the Waiting List for Liver Transplantation
An observational study of Liver Disease and Cirrhosis, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Disease, Cirrhosis
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2010to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients on the waiting list for liver transplant
Who may be able to join
- all patients who agreed to participate and signed the informed consent
Who cannot join
- those who refused to participate
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Ambulatório de Transplantes Hepáticos
Belo Horizonte, Minas Gerais
About this study
Official title: Metabolic and Nutritional Assessment in Patients on the Waiting List for Liver Transplantation
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.
- Conditions
- Liver Disease, Cirrhosis
- Keywords
- Resting metabolic rate, nutrition status, dietary intake
- Medical subject headings
- Liver Diseases, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Liver cirrhosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting energy expenditure
Assess resting energy expenditure
Measured: 12 months
Secondary outcomes (1)
Metabolic alterations - hyper or hypo metabolism
Assess the metabolic status of the patients
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startMar 2010
- Primary completionJun 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais
- Investigators
- Maria Isabel TD Correia, MD, PhD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761851
- Sponsor's protocol ID
- CDS - APQ-04415-10
- Other IDs
- CDS - APQ-04415-10
- Status last verified
- Jan 2013
- First submitted
- 3 Jan 2013
- Last updated
- 7 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
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 22411515Lee 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 22560128Anastacio 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 23011241Ferreira 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic and Nutritional Assessment in Patients on the Waiting List for Liver Transplantation
- ClinicalTrials.gov ID
- NCT01761851
- Acronym / sponsor ID
- CDS - APQ-04415-10
- Conditions
- Liver Disease, Cirrhosis
- Keywords
- Resting metabolic rate, nutrition status, dietary intake
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Liver cirrhosis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients on the waiting list for liver transplant
Key inclusion criteria (1 listed)
- all patients who agreed to participate and signed the informed consent
Key exclusion criteria (1 listed)
- those who refused to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Resting energy expenditure
Time frame: 12 months
Assess resting energy expenditure
1 secondary outcome
Metabolic alterations - hyper or hypo metabolism
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2013.
- Background: PubMed 22411515Montejo 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.
- Background: PubMed 22560128Lee 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.
- Background: PubMed 23011241Anastacio 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.
- Background: PubMed 20531175Ferreira 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Isabel TD Correia, MD, PhD principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Disease and Cirrhosis, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting energy expenditure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01761851, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2013.