Status:
COMPLETED
Effects of Weight Loss on Portal Pressure in Patients With Overweight/Obesity and Cirrhosis
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
Consorcio Centro de Investigación Biomédica en Red (CIBER)
Conditions:
Compensated Cirrhosis
Obesity
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Overweight/obesity is increasing both in the general population and in patients with cirrhosis. In compensated patients with cirrhosis increased BMI is a risk factor for clinical decompensation indepe...
Detailed Description
Overweight and obesity markedly increase the risk of appearance and progression of most chronic diseases, including chronic liver diseases. In the general population obesity is constantly and dramatic...
Eligibility Criteria
Inclusion
- Age: 18-75 years
- Compensated liver cirrhosis (diagnosed by biopsy or clear clinical, laboratory and imaging data), of any etiology; patients who presented decompensation due to gastroesophageal variceal hemorrhage can also be included if hemorrhage a) occurred \> 3 months before inclusion AND b) has been treated with drugs+band ligation AND c) no other decompensations occurred simultaneously.
- HVPG \> 5 mmHg
- BMI \> 26 Kg/m2
- Absence of gastroesophageal varices or small esophageal varices OR large varices only if the patient is already on treatment with beta-blockers since at least 6 weeks.
- In case of presence of systemic arterial hypertension and/or diabetes, patients can be included if the treatment of these condition is stable for at least 3 months
Exclusion
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01409356
Start Date
October 1 2011
End Date
December 1 2014
Last Update
March 19 2015
Active Locations (6)
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1
Hospital Clinic
Barcelona, Spain, 08036
2
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
3
Hospital Vall D'Hebron
Barcelona, Spain
4
Hospital General Universitario Gregorio Marañón
Madrid, Spain