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

Liver Cirrhosis Clinical Trial

— BCECPA  

Official title:

Body Composition Evaluation of Cirrhotic Patients With Ascites

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02421848
• Other study ID #: U São Paulo
• Status: Completed
• Phase: N/A
• First received: March 26, 2015
• Last updated: April 20, 2015
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 2014
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Ascites
• Liver Cirrhosis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Composition Evaluation of Cirrhotic Patients With Ascites (estimated by bioelectrical impedance analysis and by reference method (DXA)		two years