Sarcopenic ObesityOSaLTNCT05029713
Sarcopenic Obesity in Liver Transplanted Patients
An observational study of Sarcopenic Obesity, run by University of Bari at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sarcopenic Obesity
- What is being tested?
- Evaluation of appendicular skeletal muscle mass (ASMM) by bioelectrical impedance analysis (BIA)
- How many people
- 400 participants
- Where
- 2 sitesItaly
- Study dates
- 10 May 2021to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All liver transplanted patients who have had a liver transplant for more than one year
Who may be able to join
- patients who have had a liver transplant for more than one year
Who cannot join
- patients who have had a liver transplant for less than one year
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Evaluation of appendicular skeletal muscle mass (ASMM) by bioelectrical impedance analysis (BIA)
- Keywords
- liver transplantation, obesity, sarcopenia, calcineurin inhibitors
- Medical subject headings
- Obesity, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of appendicular skeletal muscle mass (ASMM) by bioelectrical impedance analysis (BIA)Diagnostic test
Also called 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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Evaluation of appendicular skeletal muscle mass (ASMM) by bioelectrical impedance analysis (BIA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment
Secondary outcomes (1)
The possible involvement of calcineurine inhibitors in patients with sarcopenic obesity
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.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start10 May 2021
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Sarcopenic ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Maria Grano
- Responsible party
- Principal investigator, Michele Barone, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029713
- Sponsor's protocol ID
- Policlinico 8
- Acronym
- OSaLT
- Status last verified
- May 2024
- First submitted
- 17 Jul 2021
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28488418Barone 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.
PubMed 28801180Rezende 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.
PubMed 23165585Everhart 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.
PubMed 9649642Richards 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.
PubMed 15773968Beckmann 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.
PubMed 28008650Hanai 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.
PubMed 25441595Masuda 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.
PubMed 24357065Schiavo 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.
PubMed 30122874Hudson 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.
PubMed 23838168
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenic Obesity and Associated Risk Factors in Patients Undergone Liver Transplant
- ClinicalTrials.gov ID
- NCT05029713
- Acronym / sponsor ID
- OSaLT / Policlinico 8
- Conditions
- Sarcopenic Obesity
- Keywords
- liver transplantation, obesity, sarcopenia, calcineurin inhibitors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of BariUniversity, hospital or other
- Collaborators
- Prof. Maria Grano
- Study start
- 10 May 2021 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| liver transplanted patients without sarcopenic obesity (controls) | – | Diagnostic Test: Evaluation of appendicular skeletal muscle mass (ASMM) by bioelectrical impedance analysis (BIA)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. |
| liver transplanted patients with sarcopenic obesity (cases) | – | Diagnostic Test: Evaluation of appendicular skeletal muscle mass (ASMM) by bioelectrical impedance analysis (BIA)All liver transplanted patients followed as outpatients at out clinic, with both muscle strenght and muscle mass. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All liver transplanted patients who have had a liver transplant for more than one year
Key inclusion criteria (1 listed)
- patients who have had a liver transplant for more than one year
Key exclusion criteria (1 listed)
- patients who have had a liver transplant for less than one year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of appendicular skeletal muscle mass (ASMM) by bioelectrical impedance analysis (BIA)Also: 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 bingeThe 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. | Diagnostic test | liver transplanted patients with sarcopenic obesity (cases), liver transplanted patients without sarcopenic obesity (controls) |
Primary outcome
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.
1 secondary outcome
The possible involvement of calcineurine inhibitors in patients with sarcopenic obesity
Time frame: At enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Background: PubMed 28488418Barone 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.
- Background: PubMed 28801180Barone 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.
- Background: PubMed 23165585Rezende 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.
- Background: PubMed 9649642Everhart 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.
- Background: PubMed 15773968Richards 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.
- Background: PubMed 28008650Beckmann 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.
- Background: PubMed 25441595Hanai 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.
- Background: PubMed 24357065Masuda 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.
- Background: PubMed 30122874Schiavo 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.
- Background: PubMed 23838168Hudson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenic Obesity, run by University of Bari at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sarcopenic obesity prevalence in liver transplanted patients (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05029713, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.