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OpenTrials
Completed

NCT Number: NCT02421848

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Body Composition Evaluation of Cirrhotic Patients With Ascites

Acronym: BCECPA

Important dates

Study start
2012
Primary completion
2012
Study completion
2014
First posted
Apr 21, 2015
Registry last updated
Apr 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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