NCT01409356

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2011

Typical duration for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

2.3 years

First QC Date

August 3, 2011

Last Update Submit

March 17, 2015

Conditions

Compensated CirrhosisObesity

Keywords

ObesityPortal hypertensionCirrhosisDietExercise

Outcome Measures

Primary Outcomes (1)

  • HVPG change

    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.

    4 months

Secondary Outcomes (3)

  • Hepatic function

    4 months

  • Serum markers of fibrosis, angiogenesis, endothelial dysfunction and oxidative stress

    4 months

  • Body adiposity changes

    4 months

Study Arms (1)

Diet+Exercise

EXPERIMENTAL

Program of weight loss through diet+exercise (=intervention)

Behavioral: Diet + exercise

Interventions

Diet + exerciseBEHAVIORAL

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.

Diet+Exercise

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18-75 years
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital Clinic

Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital Vall D'Hebron

Barcelona, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Location

Hospital Puerta de Hierro

Madrid, Spain

Location

Universitario Ramón y Cajal

Madrid, Spain

Location

Related Publications (1)

  • Berzigotti A, Albillos A, Villanueva C, Genesca J, Ardevol A, Augustin S, Calleja JL, Banares R, Garcia-Pagan JC, Mesonero F, Bosch J; Ciberehd SportDiet Collaborative Group. Effects of an intensive lifestyle intervention program on portal hypertension in patients with cirrhosis and obesity: The SportDiet study. Hepatology. 2017 Apr;65(4):1293-1305. doi: 10.1002/hep.28992. Epub 2017 Mar 6.

    PMID: 27997989DERIVED

MeSH Terms

Conditions

ObesityHypertension, PortalFibrosisMotor Activity

Interventions

DietExercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System DiseasesPathologic ProcessesBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jaime Bosch, MD

    Hospital Clinic and CIBERehd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

August 3, 2011

First Posted

August 4, 2011

Study Start

October 1, 2011

Primary Completion

February 1, 2014

Study Completion

December 1, 2014

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations

ES(6)