Effects of Weight Loss on Portal Pressure in Patients With Overweight/Obesity and Cirrhosis (SPORTDIET)
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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 |
- 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.
- 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 2013 |
| Estimated Primary Completion Date: | December 2012 (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 |
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 hemorrage 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| Contact: Jaime Bosch, MD | +3493227400 ext 5790 | jbosch@clinic.ub.es |
| Contact: Annalisa Berzigotti, MD | +3493227400 ext 3314 | aberzigo@clinic.ub.es |
| Spain | |
| Hospital Clinic | Not yet recruiting |
| Barcelona, Spain, 08036 | |
| Contact: Jaime Bosch, MD +34932275400 ext 5790 jbosch@clinic.ub.es | |
| Principal Investigator: Jaime Bosch, MD | |
| Sub-Investigator: Annalisa Berzigotti, MD | |
| Sub-Investigator: Juan G Abraldes, MD | |
| Sub-Investigator: Juan Carlos Garcia-Pagan, MD | |
| Hospital Vall D'Hebron | Not yet recruiting |
| Barcelona, Spain | |
| Contact: Joan Genesca, MD jgenesca@vhebron.net | |
| Principal Investigator: Joan Genesca, MD | |
| Sub-Investigator: Antonio Gonzalez, MD | |
| Sub-Investigator: Salvador Augustin, MD | |
| Hospital de la Santa Creu i Sant Pau | Not yet recruiting |
| Barcelona, Spain | |
| Contact: Candid Villanueva, MD cvillanueva@santpau.cat | |
| Principal Investigator: Candid Villanueva, MD | |
| Sub-Investigator: Alan Colomo, MD | |
| Hospital Puerta de Hierro | Not yet recruiting |
| Madrid, Spain | |
| Contact: Jose Luis Calleja, MD jlcpan@teleline.es | |
| Principal Investigator: Jose Luis Calleja, MD | |
| Sub-Investigator: Elba Llop, MD | |
| Universitario Ramón y Cajal | Not yet recruiting |
| Madrid, Spain | |
| Contact: Agustin Albillos, MD aalbillosm@meditex.es | |
| Principal Investigator: Agustin Albillos, MD | |
| Hospital General Universitario Gregorio Marañón | Not yet recruiting |
| Madrid, Spain | |
| Contact: Rafael Bañares, MD Rbanares@telefonica.net | |
| Sub-Investigator: Cristina Ripoll, MD | |
| Principal Investigator: Rafael Bañares, MD | |
| Principal Investigator: | Jaime Bosch, MD | Hospital Clinic and CIBERehd |
More Information
No publications provided
| Responsible Party: | Jaime Bosch, Hospital Clinic and CIBERehd. Barcelona |
| ClinicalTrials.gov Identifier: | NCT01409356 History of Changes |
| Other Study ID Numbers: | SPORTDIET |
| Study First Received: | August 3, 2011 |
| Last Updated: | August 3, 2011 |
| 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 May 16, 2013