Sarcopenic Obesity in Liver Transplanted Patients (OSaLT)

May 9, 2024 updated by: Michele Barone, University of Bari

Sarcopenic Obesity and Associated Risk Factors in Patients Undergone Liver Transplant

The prevalence of obesity in cirrhotic patients who are candidates for liver transplantation (LT) is increasing, a phenomenon consistent with the increased prevalence of obesity in the general population. On the other hand, in liver patients on the waiting list for transplantation it is often observed sarcopenia. The combination of the two condition is defined sarcopenic obesity, which combines the negative synergy deriving from the two conditions. In this study the investigators will evaluate, for the first time, the prevalence of sarcopenic obesity in subjects undergone LT and determine the possible associated risk factors, particularly the role of immunosuppressive treatment with calcineurin inhibitors in addition to dietary habits and physical activity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obesity is a clinical condition characterized by excessive body weight due to the accumulation of adipose tissue, which represents a risk to health. In particular, obesity represents a risk factor for cardiovascular diseases, metabolic syndrome, NAFLD, and significantly increases the risk of mortality compared to normal weight subjects. It has been reported that the presence of obesity represents a risk factor for post-operative complications in patients undergone LT, increasing the mortality risk in those with the highest degree of obesity. At the same time, an evaluation obesity on the basis of body mass index (BMI) does not take in account the real body composition in terms of fat mass and muscle mass, which are more effective prognostic factors. Data of the literature report that patients undergoing liver transplantation (LT) have an average weight gain of 9 kg during the first year following the transplant, whereas in the second year, it would be observed about 24% incidence of obesity that would reach 30-38% in the third year. However, in all these studies the evaluation of de novo obesity is biased by the lack of data on the body weight of the patients prior their inclusion in the waiting list or to the use of dry body weight in patients mostly decompensated, or the loss of patients at the follow up. On the other hand, in liver patients on the waiting list for transplantation it is often observed sarcopenia, a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength associated with an increased risk of adverse events such as disability, poor quality of life and death. In this clinical setting, it has been reported in a percentage ranging from 41% to 68 %.

The combination of the two condition defined sarcopenic obesity, which combines the negative synergy deriving from the two conditions, has been reported to be 20-40% in patients on the waiting list for liver transplantation. In addition, calcineurin inhibitors, which represent the backbone of anti-rejection therapy, have been investigated for their negative effect on muscle mass.

In this study the investigators will evaluate, for the first time, the prevalence of sarcopenic obesity in subjects undergone LT and assess the possible associated risk factors, particularly the role of immunosuppressive treatment with calcineurin inhibitors (Ciclosporin and Tacrolimus), iin addition to dietary habits and physical activity. To achieve this goal the investigators will first screen all liver transplanted patients for muscle strenght and then all subjects with reduced muscle strenght will undergo bioelectrical impedance analysis (BIA). The presence of both conditions will allow us to identify subjects with sarcopenic obesity.

Finally, the immunosuppressive therapy will be compared in liver transplanted patients with and without sarcopenic obesity. The evaluation of risk factors for obesity will be completing by the assessment of dietary habits and physical activity.

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70124
        • Policlinic Hospital
    • BA
      • Bari, BA, Italy, 70124
        • Policlinic Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All liver transplanted patients who have had a liver transplant for more than one year

Description

Inclusion Criteria:

  • patients who have had a liver transplant for more than one year

Exclusion Criteria:

  • patients who have had a liver transplant for less than one year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
liver transplanted patients without sarcopenic obesity (controls)
All liver transplanted patients followed as outpatients at out clinic, which lack at least one of the two conditions (muscle strenght and muscle mass) used to identify sarcopenic obesity.
Diagnostic test: Evaluation of appendicular skeletal muscle mass (ASMM) by bioelectrical impedance analysis (BIA)
The use of handgrip dynamometer and BIA will be used to screen all liver transplanted patients for sarcopenic obesity, using a muscle strength cut-off <27 Kg in men and <16 Kg in women and a standardized muscle mass cut-off <0.789 ASMM/BMI for men and 0.512 ASMM/BMI for women.
Other Names:
  • Evaluation of muscle strenght by an handgrip dynamometer
  • Evaluation of physical activity by the International Physical Activity Questionnaire (IPAQ)
  • The Yale Food Addiction Scale will be used to exclude risk of patients to binge
liver transplanted patients with sarcopenic obesity (cases)
All liver transplanted patients followed as outpatients at out clinic, with both muscle strenght and muscle mass.
Diagnostic test: Evaluation of appendicular skeletal muscle mass (ASMM) by bioelectrical impedance analysis (BIA)
The use of handgrip dynamometer and BIA will be used to screen all liver transplanted patients for sarcopenic obesity, using a muscle strength cut-off <27 Kg in men and <16 Kg in women and a standardized muscle mass cut-off <0.789 ASMM/BMI for men and 0.512 ASMM/BMI for women.
Other Names:
  • Evaluation of muscle strenght by an handgrip dynamometer
  • Evaluation of physical activity by the International Physical Activity Questionnaire (IPAQ)
  • The Yale Food Addiction Scale will be used to exclude risk of patients to binge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sarcopenic obesity prevalence in liver transplanted patients
Time Frame: At enrollment
In all obese patients identified by a body mass index (BMI) ≥ 30 the investigators will first evaluate muscle strenght and those subjects with a reduction of muscle strenght (muscle strength <27 Kg in men and <16 Kg in women) will undergo the evaluation of muscle mass by bioelectrical impedance analysis; in the latter case the appendicular skeletal muscle mass (ASM) will be standardized for BMI (ASM/BMI), and the cut-offs considered will be <0.789 for men and <0.512 for women.
At enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The possible involvement of calcineurine inhibitors in patients with sarcopenic obesity
Time Frame: At enrollment
The investigators will compare the prevalence of sarcopenic obesity in subjects receiving calcineurin with that observed in subjects receiving other therapies by the Chi squared or Fisher test. In case of a significantly different prevalence between the two groups, a multivariate analysis will be performed to confirm if calcineurin inhibitor therapy is an indipendent risk factor for sarcopenic obesity.
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bari

Collaborators

Prof. Maria Grano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2021

Primary Completion (Actual)

October 30, 2023

Study Completion (Actual)

October 30, 2023

Study Registration Dates

First Submitted

July 17, 2021

First Submitted That Met QC Criteria

August 25, 2021

First Posted (Actual)

August 31, 2021

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 9, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Policlinico 8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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