Obesity Clinical Trial
Official title:
Effects of Weight Loss on Portal Pressure in Patients With Compensated Cirrhosis and Overweight/Obesity
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 independent of liver function and portal pressure. Nonetheless, patients with cirrhosis and obesity show a progressive increase in portal pressure, which might explain their increased risk of complications. Since obesity is a potentially modifiable risk factor, we designed this proof-of-concept study to assess the effects of weight loss (obtained by 4 months of diet and exercise) on portal pressure in patients with compensated cirrhosis and overweight/obesity.
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 dramatically raising, and represents a global epidemics. In a study including
both European and American patients, our group reported that in patients with compensated
cirrhosis overweight/obesity is very frequently observed (55% OW, 15% OB in Spanish
patients; > 50% OB in USA patients), being the figure similar to that of general population.
Moreover, this study demonstrated that the increase in body mass index (BMI) is a risk
factor for the development of decompensation of cirrhosis, independent of portal pressure
and liver function (Berzigotti et al. Hepatology 2011). We also observed that included
patients with cirrhosis and obesity showed a significant increase of portal pressure
(estimated through hepatic venous pressure gradient measurement-HVPG), which was not found
in OW or normal weight patients. This suggests that the mechanism inducing decompensation in
obese patients with cirrhosis might be mediated by an increase in portal pressure, even if
no data are available in this population to support this hypothesis. It is well known that
in obesity the adipose tissue acquires a pro-inflammatory phenotype leading to increased
release of IL-1, IL-6 and TNF-alfa and many other pro-fibrogenic cytokines and hormones,
which might mediate also an increase in portal pressure.
Given these observation, and given the potential reversibility of OW/OB, we hypothesise that
weight loss (obtained by diet and exercise) might effectively reduce the HVPG in patients
with compensated cirrhosis and OW/OB, so reducing their risk to progression. We designed
this proof-of-concept study to confirm this hypothesis.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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