Sarcopenic Obesity in Liver Transplanted Patients

NCT ID: NCT05029713

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-10
• Study Completion Date: 2023-10-30

Brief Summary

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.

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.

Conditions

Sarcopenic Obesity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Evaluation of appendicular skeletal muscle mass (ASMM) by bioelectrical impedance analysis (BIA)

Intervention Type: DIAGNOSTIC_TEST

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.

liver transplanted patients with sarcopenic obesity (cases)

All liver transplanted patients followed as outpatients at out clinic, with both muscle strenght and muscle mass.

Evaluation of appendicular skeletal muscle mass (ASMM) by bioelectrical impedance analysis (BIA)

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention 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

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof. Maria Grano

UNKNOWN

Sponsor Role: collaborator

University of Bari

OTHER

Sponsor Role: lead

Responsible Party

Michele Barone

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Policlinic Hospital

Bari, BA, Italy

Policlinic Hospital

Bari, , Italy

Countries

Italy

References

Barone M, Viggiani MT, Losurdo G, Principi M, Leandro G, Di Leo A. Systematic review with meta-analysis: post-operative complications and mortality risk in liver transplant candidates with obesity. Aliment Pharmacol Ther. 2017 Aug;46(3):236-245. doi: 10.1111/apt.14139. Epub 2017 May 10.

Reference Type: BACKGROUND

PMID: 28488418 (View on PubMed)

Barone M, Viggiani MT, Avolio AW, Iannone A, Rendina M, Di Leo A. Obesity as predictor of postoperative outcomes in liver transplant candidates: Review of the literature and future perspectives. Dig Liver Dis. 2017 Sep;49(9):957-966. doi: 10.1016/j.dld.2017.07.004. Epub 2017 Jul 22.

Reference Type: BACKGROUND

PMID: 28801180 (View on PubMed)

Rezende Anastacio L, Garcia Ferreira L, Costa Liboredo J, de Sena Ribeiro H, Soares Lima A, Garcia Vilela E, Correia MI. Overweight, obesity and weight gain up to three years after liver transplantation. Nutr Hosp. 2012 Jul-Aug;27(4):1351-6. doi: 10.3305/nh.2012.27.4.5768.

Reference Type: BACKGROUND

PMID: 23165585 (View on PubMed)

Everhart JE, Lombardero M, Lake JR, Wiesner RH, Zetterman RK, Hoofnagle JH. Weight change and obesity after liver transplantation: incidence and risk factors. Liver Transpl Surg. 1998 Jul;4(4):285-96. doi: 10.1002/lt.500040402.

Reference Type: BACKGROUND

PMID: 9649642 (View on PubMed)

Richards J, Gunson B, Johnson J, Neuberger J. Weight gain and obesity after liver transplantation. Transpl Int. 2005 Apr;18(4):461-6. doi: 10.1111/j.1432-2277.2004.00067.x.

Reference Type: BACKGROUND

PMID: 15773968 (View on PubMed)

Beckmann S, Nikolic N, Denhaerynck K, Binet I, Koller M, Boely E, De Geest S; Psychosocial Interest Group, Swiss Transplant Cohort Study. Evolution of body weight parameters up to 3 years after solid organ transplantation: The prospective Swiss Transplant Cohort Study. Clin Transplant. 2017 Mar;31(3). doi: 10.1111/ctr.12896. Epub 2017 Jan 24.

Reference Type: BACKGROUND

PMID: 28008650 (View on PubMed)

Hanai T, Shiraki M, Nishimura K, Ohnishi S, Imai K, Suetsugu A, Takai K, Shimizu M, Moriwaki H. Sarcopenia impairs prognosis of patients with liver cirrhosis. Nutrition. 2015 Jan;31(1):193-9. doi: 10.1016/j.nut.2014.07.005. Epub 2014 Jul 30.

Reference Type: BACKGROUND

PMID: 25441595 (View on PubMed)

Masuda T, Shirabe K, Ikegami T, Harimoto N, Yoshizumi T, Soejima Y, Uchiyama H, Ikeda T, Baba H, Maehara Y. Sarcopenia is a prognostic factor in living donor liver transplantation. Liver Transpl. 2014 Apr;20(4):401-7. doi: 10.1002/lt.23811. Epub 2014 Jan 27.

Reference Type: BACKGROUND

PMID: 24357065 (View on PubMed)

Schiavo L, Busetto L, Cesaretti M, Zelber-Sagi S, Deutsch L, Iannelli A. Nutritional issues in patients with obesity and cirrhosis. World J Gastroenterol. 2018 Aug 14;24(30):3330-3346. doi: 10.3748/wjg.v24.i30.3330.

Reference Type: BACKGROUND

PMID: 30122874 (View on PubMed)

Hudson MB, Price SR. Calcineurin: a poorly understood regulator of muscle mass. Int J Biochem Cell Biol. 2013 Oct;45(10):2173-8. doi: 10.1016/j.biocel.2013.06.029. Epub 2013 Jul 6.

Reference Type: BACKGROUND

PMID: 23838168 (View on PubMed)

Other Identifiers

Policlinico 8

Identifier Type: -

Identifier Source: org_study_id