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

NCT ID: NCT02421848

Last Updated: 2015-04-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 112 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-12-31

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.

Conditions

Liver Cirrhosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cirrhotic Patients With Ascites

Cirrhotic Patients With Ascites

No interventions assigned to this group

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Dan Linetzky Waitzberg

Dan Linetzky Waitzberg

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 30007480 (View on PubMed)

Other Identifiers

U São Paulo

Identifier Type: -

Identifier Source: org_study_id