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

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT02421848

Collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)

112

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhosis

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.

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.

Study Design

Study Type:

Observational

Actual Enrollment :

112 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Body Composition Evaluation of Cirrhotic Patients With Ascites

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Cirrhotic Patients With Ascites Cirrhotic Patients With Ascites

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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;

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dan Linetzky Waitzberg, Dan Linetzky Waitzberg, University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT02421848

Other Study ID Numbers:

U São Paulo

First Posted:

Apr 21, 2015

Last Update Posted:

Apr 21, 2015

Last Verified:

Apr 1, 2015

Keywords provided by Dan Linetzky Waitzberg, Dan Linetzky Waitzberg, University of Sao Paulo

Body composition

Sarcopenia

Cirrhotic with Ascites

Additional relevant MeSH terms:

Liver Cirrhosis

Ascites

Study Results

No Results Posted as of Apr 21, 2015