Effects of Weight Loss on Portal Pressure in Patients With Overweight/Obesity and Cirrhosis (SPORTDIET)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Centro de Investigación Biomédica en Red
Information provided by (Responsible Party):
Jaime Bosch, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01409356
First received: August 3, 2011
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Compensated Cirrhosis
Overweight or Obesity
Behavioral: Diet + exercise
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Weight Loss on Portal Pressure in Patients With Compensated Cirrhosis and Overweight/Obesity

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • HVPG change [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    The effects of weight loss on portal pressure will be assessed by measuring the HVPG at baseline and after 4 months of diet+exercise in the included patients.


Secondary Outcome Measures:
  • Hepatic function [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    The effects of weight loss on liver function will be estimated by assessing standard liver tests and indocyanine green clearance at baseline and after 4 months of diet+exercise

  • Serum markers of fibrosis, angiogenesis, endothelial dysfunction and oxidative stress [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    The effects of weight loss on Serum markers of fibrosis, angiogenesis, endothelial dysfunction and oxidative stress will be assessed by extracting adequate blood samples at baseline and after 4 months of diet+exercise

  • Body adiposity changes [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Changes in BMI and body fat% will be assessed by measuring body weight and % of fat at baseline and after 4 months of diet + exercise.


Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: December 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diet+Exercise
All patients will be included in a program of weight loss through diet+exercise (see intervention).
Behavioral: Diet + exercise
All patients will be included in a program of dietary counselling by dietists, who will periodically follow-up the patient to achieve weight loss; moreover a fitness professional will instruct and train the patients twice a week to enhance their physical activity. A step counter will be also given to all participants and daily step count will be recorded. The duration of diet+exercise is 4 months from baseline HVPG measurement.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01409356

Locations
Spain
Hospital Clinic
Barcelona, Spain, 08036
Hospital Vall D'Hebron
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Puerta de Hierro
Madrid, Spain
Universitario Ramón y Cajal
Madrid, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Sponsors and Collaborators
Hospital Clinic of Barcelona
Centro de Investigación Biomédica en Red
Investigators
Principal Investigator: Jaime Bosch, MD Hospital Clinic and CIBERehd
  More Information

No publications provided

Responsible Party: Jaime Bosch, Prof., Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01409356     History of Changes
Other Study ID Numbers: SPORTDIET
Study First Received: August 3, 2011
Last Updated: February 13, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Clinic of Barcelona:
Obesity
Portal hypertension
Cirrhosis
Diet
Exercise

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Obesity
Weight Loss
Overweight
Liver Diseases
Digestive System Diseases
Pathologic Processes
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on August 20, 2014