- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
---|
Cirrhotic Patients With Ascites
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Body Composition Evaluation of Cirrhotic Patients With Ascites (estimated by bioelectrical impedance analysis and by reference method (DXA)
Tidsram: two years
|
two years
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- U São Paulo
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