- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02421848
Lean Mass Evaluation of Cirrhotic Patients With Ascites With the Use DXA (BCECPA)
Body Composition Evaluation of Cirrhotic Patients With Ascites
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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;
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
Cirrhotic Patients With Ascites
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Body Composition Evaluation of Cirrhotic Patients With Ascites (estimated by bioelectrical impedance analysis and by reference method (DXA)
Tidsramme: two years
|
two years
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- U São Paulo
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