Sarcopenic Obesity in Liver Transplanted Patients

NCT05029713 | Completed

• 1 other identifier: Policlinico 8
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

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.

Conditions

Sarcopenic Obesity

Keywords

liver transplantation; obesity; sarcopenia; calcineurin inhibitors

Outcome Measures

Primary Outcomes (1)

• Sarcopenic obesity prevalence in liver transplanted patients

  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 Outcomes (1)

• The possible involvement of calcineurine inhibitors in patients with sarcopenic obesity

  At enrollment

Study Arms (2)

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)

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)

Interventions

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

Also known as: 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); liver transplanted patients without sarcopenic obesity (controls)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Bari: lead
• Prof. Maria Grano: collaborator

Study Sites (2)

Policlinic Hospital

Bari, BA, 70124, Italy

Location

Policlinic Hospital

Bari, 70124, Italy

Location

Related Publications (10)

• 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.

  PMID: 28488418 BACKGROUND

• 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.

  PMID: 28801180 BACKGROUND

• 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.

  PMID: 23165585 BACKGROUND

• 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.

  PMID: 9649642 BACKGROUND

• 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.

  PMID: 15773968 BACKGROUND

• 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.

  PMID: 28008650 BACKGROUND

• 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.

  PMID: 25441595 BACKGROUND

• 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.

  PMID: 24357065 BACKGROUND

• 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.

  PMID: 30122874 BACKGROUND

• 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.

  PMID: 23838168 BACKGROUND

MeSH Terms

Conditions

Obesity; Sarcopenia

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 17, 2021
• First Posted: August 31, 2021
• Study Start: May 10, 2021
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)