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Clinical Trials/NCT02421848
NCT02421848
Completed
Not Applicable

Body Composition Evaluation of Cirrhotic Patients With Ascites

University of Sao Paulo0 sites112 target enrollmentJanuary 2012
ConditionsLiver Cirrhosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Liver Cirrhosis
Sponsor
University of Sao Paulo
Enrollment
112
Primary Endpoint
Body Composition Evaluation of Cirrhotic Patients With Ascites (estimated by bioelectrical impedance analysis and by reference method (DXA)
Status
Completed
Last Updated
11 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
December 2014
Last Updated
11 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dan Linetzky Waitzberg

Dan Linetzky Waitzberg

University of Sao Paulo

Eligibility Criteria

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;

Outcomes

Primary Outcomes

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

Time Frame: two years

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