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CompletedNCT02421848BCECPAUpdated Apr 21, 2015

Lean Mass Evaluation of Cirrhotic Patients With Ascites With the Use DXA

An observational study in Liver Cirrhosis, sponsored by University of Sao Paulo. Completed. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-21.

Sponsored by University of Sao Paulo · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
112
Ages
18 Years and older
Sex
Male
01

Study summary

Malnutrition due to liver disease is common, however, their detection is difficult. The parameters used for nutritional assessment in clinical practice have limited use in this patient population.

From this perspective, this study proposes to develop predictive equations for body composition for electrical bioimpedance (BIA) in cirrhotic patients. Besides being a fast and risk free, the BIA offers the additional advantage of low cost compared to other methods that assess body composition (BC).

Will be selected patients male with liver cirrhosis (n = 112) of the Liver Transplant Clinic of the Hospital of the Clinicas, Faculty of Medicine, University of São Paulo.

This pioneering study is of great clinical importance because malnutrition is a relevant factor in the prognosis of liver disease and there is not efficient method in clinical practice to properly assess the body composition in this population.

Read the detailed description

Malnutrition due to liver disease is common, however, their detection is difficult. The parameters used for nutritional assessment in clinical practice have limited use in this patient population.

From this perspective, this study proposes to develop predictive equations for body composition for electrical bioimpedance (BIA) in cirrhotic patients. Besides being a fast and risk free, the BIA offers the additional advantage of low cost compared to other methods that assess body composition (BC).

Will be selected patients male with liver cirrhosis (n = 112) of the Liver Transplant Clinic of the Hospital of the Clinicas, Faculty of Medicine, University of São Paulo. After signing an informed consent, BC will be estimated by bioelectrical impedance analysis and by reference method (DXA). The data obtained by both methods are statistically treated to obtain specific BIA prediction equations for the evaluation of cirrhotic patients.

This pioneering study is of great clinical importance because malnutrition is a relevant factor in the prognosis of liver disease and there is not efficient method in clinical practice to properly assess the body composition in this population. Such knowledge, in turn, can serve as a new tool for nutritional assistance in treating this disease.

02

Conditions studied

  • Liver Cirrhosis

Keywords

  • Body composition
  • Sarcopenia
  • Cirrhotic with Ascites
03

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's enrollment of 112 is below the median of 151 across 587 observational studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Will be selected patients male with liver cirrhosis (n = 112) of the Liver Transplant Clinic of the Hospital of the Clinicas, Faculty of Medicine, University of São Paulo.

Inclusion criteria

  • Adults (18-60 years) of both sexes;
  • Signing the free and informed consent;
  • Show interest, conditions and availability to participate in all procedures included in the study protocol;
  • liver cirrhosis Carrier

Exclusion criteria

Exclusion Criteria:

  • Refusal to participate;
  • Patients who have made liver transplantation;
  • Physical Amputation;
  • Swelling in the lower limb;
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
112 participants (actual)
Patient registry
No

Groups and cohorts

  • Cirrhotic Patients With Ascites

    Cirrhotic Patients With Ascites

06

What researchers measure

Primary outcomes

  1. Body Composition Evaluation of Cirrhotic Patients With Ascites (estimated by bioelectrical impedance analysis and by reference method (DXA)

    Time frame: two years

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Belarmino G, Singer P, Gonzalez MC, Machado NM, Cardinelli CS, Barcelos S, Andraus W, D'Albuquerque LAC, Damiani L, Costa AC, Pereira RMR, Heymsfield SB, Sala P, Torrinhas RSM, Waitzberg DL. Prognostic value of energy expenditure and respiratory quotient measuring in patients with liver cirrhosis. Clin Nutr. 2019 Aug;38(4):1899-1904. doi: 10.1016/j.clnu.2018.07.001. Epub 2018 Jul 6. PubMed 30007480 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02421848
Lead sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
Responsible party
Dan Linetzky Waitzberg (Dan Linetzky Waitzberg, University of Sao Paulo) — Principal investigator
First posted
Apr 21, 2015
Start date
Jan 2012
Primary completion
May 2012
Completion
Dec 2014
Last update
Apr 21, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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