CirrhosisNCT03458845
Prevalence of Sarcopenia and Undernutrition in Patients With Cirrhosis and Abdominal Hernia
An observational study of Cirrhosis and Sarcopenia, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The study evaluates whether sarcopenia influences the prevalence of abdominal hernias in patients with cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Sarcopenia, Malnutrition
- What is being tested?
- Computed Tomography Scan
- How many people
- 140 participants
- Where
- 1 siteBrazil
- Study dates
- 30 May 2018to 20 Apr 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tertiary care adult patients with cirrhosis, with and without abdominal hernias.
Who may be able to join
- ≥ 18 years
- Previous diagnosis of cirrhosis
Who cannot join
- Acutely decompensated cirrhosis
- Other chronic diseases in advanced stage (e.g. cardiac failure, chronic obstructive pulmonary disease, cancer)
- Cognitive impairment, delirium, non-controlled psychosis
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo
About this study
The study evaluates whether sarcopenia influences the prevalence of abdominal hernias in patients with cirrhosis.
Read the detailed description
Sarcopenia is a common condition in patients with cirrhosis, with a prevalence of around 50%. It is unknown if the presence of sarcopenia may influence the prevalence of abdominal hernias in this group of patients. Clinical, nutritional and radiological evaluation will be performed in two groups of cirrhotic patients to evaluate this hypothesis.
- Conditions
- Cirrhosis, Sarcopenia, Malnutrition, Hernia, Abdominal
- Being tested
- Computed Tomography Scan
- Keywords
- Cirrhosis, Sarcopenia, Malnutrition, Inguinal hernia, Umbilical hernia, Undernutrition
- Medical subject headings
- Fibrosis, Sarcopenia, Malnutrition, Hernia, Abdominal, Hernia, Inguinal, Hernia, Umbilical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed Tomography ScanDiagnostic test
Also called Hand-grip test (dynamometer), Royal Free Hospital-Global Assessment
The results of the CT scan and the hand-grip test will be used for diagnosis of sarcopenia. The Royal Free Hospital-Global Assessment (RFH-GA) results will classify the nutritional status of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | This group consists of cirrhotic patients with any abdominal hernia Receives: Diagnostic Test: Computed Tomography Scan | |
| Group 2 | This group consists of cirrhotic patients without any hernias Receives: Diagnostic Test: Computed Tomography Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Sarcopenia
Prevalence of Sarcopenia in patients with cirrhosis
Measured: Through study completion (an average of 1 year)
Influence of Sarcopenia in Prevalence of Abdominal Hernias in Patients with Cirrhosis
Influence of Sarcopenia in Prevalence of Abdominal Hernias in Patients with Cirrhosis
Measured: Through study completion (an average of 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start30 May 2018
- Primary completion15 Jan 2021
- Study completion20 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Meyer, MD PhD FACS, University of Sao Paulo
- Investigators
- Alberto Meyer, PhD, Principal investigator, Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458845
- Sponsor's protocol ID
- 81063817.0.0000.0068
- Status last verified
- Apr 2021
- First submitted
- 26 Feb 2018
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Montano-Loza AJ. Clinical relevance of sarcopenia in patients with cirrhosis. World J Gastroenterol. 2014 Jul 7;20(25):8061-71. doi: 10.3748/wjg.v20.i25.8061.
PubMed 25009378Kalafateli M, Konstantakis C, Thomopoulos K, Triantos C. Impact of muscle wasting on survival in patients with liver cirrhosis. World J Gastroenterol. 2015 Jun 28;21(24):7357-61. doi: 10.3748/wjg.v21.i24.7357.
PubMed 26139982Morgan MY, Madden AM, Soulsby CT, Morris RW. Derivation and validation of a new global method for assessing nutritional status in patients with cirrhosis. Hepatology. 2006 Oct;44(4):823-35. doi: 10.1002/hep.21358.
PubMed 17006918Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
PubMed 20392703
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Sarcopenia and Undernutrition in Patients With Cirrhosis and Abdominal Hernia
- ClinicalTrials.gov ID
- NCT03458845
- Acronym / sponsor ID
- 81063817.0.0000.0068
- Conditions
- Cirrhosis, Sarcopenia, Malnutrition, Hernia, Abdominal
- Keywords
- Cirrhosis, Sarcopenia, Malnutrition, Inguinal hernia, Umbilical hernia, Undernutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 30 May 2018 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 8 Mar 2018 (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 study evaluates whether sarcopenia influences the prevalence of abdominal hernias in patients with cirrhosis.
Detailed description
Sarcopenia is a common condition in patients with cirrhosis, with a prevalence of around 50%. It is unknown if the presence of sarcopenia may influence the prevalence of abdominal hernias in this group of patients. Clinical, nutritional and radiological evaluation will be performed in two groups of cirrhotic patients to evaluate this hypothesis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Computed Tomography ScanThis group consists of cirrhotic patients with any abdominal hernia |
| Group 2 | – | Diagnostic Test: Computed Tomography ScanThis group consists of cirrhotic patients without any hernias |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary care adult patients with cirrhosis, with and without abdominal hernias.
Key inclusion criteria (2 listed)
- ≥ 18 years
- Previous diagnosis of cirrhosis
Key exclusion criteria (3 listed)
- Acutely decompensated cirrhosis
- Other chronic diseases in advanced stage (e.g. cardiac failure, chronic obstructive pulmonary disease, cancer)
- Cognitive impairment, delirium, non-controlled psychosis
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 |
|---|---|---|
| Computed Tomography ScanAlso: Hand-grip test (dynamometer), Royal Free Hospital-Global AssessmentThe results of the CT scan and the hand-grip test will be used for diagnosis of sarcopenia. The Royal Free Hospital-Global Assessment (RFH-GA) results will classify the nutritional status of the patient. | Diagnostic test | Group 1, Group 2 |
Primary outcome
Prevalence of Sarcopenia
Time frame: Through study completion (an average of 1 year)
Prevalence of Sarcopenia in patients with cirrhosis
Influence of Sarcopenia in Prevalence of Abdominal Hernias in Patients with Cirrhosis
Time frame: Through study completion (an average of 1 year)
Influence of Sarcopenia in Prevalence of Abdominal Hernias in Patients with Cirrhosis
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 27 Apr 2021.
- Background: PubMed 25009378Montano-Loza AJ. Clinical relevance of sarcopenia in patients with cirrhosis. World J Gastroenterol. 2014 Jul 7;20(25):8061-71. doi: 10.3748/wjg.v20.i25.8061.
- Background: PubMed 26139982Kalafateli M, Konstantakis C, Thomopoulos K, Triantos C. Impact of muscle wasting on survival in patients with liver cirrhosis. World J Gastroenterol. 2015 Jun 28;21(24):7357-61. doi: 10.3748/wjg.v21.i24.7357.
- Background: PubMed 17006918Morgan MY, Madden AM, Soulsby CT, Morris RW. Derivation and validation of a new global method for assessing nutritional status in patients with cirrhosis. Hepatology. 2006 Oct;44(4):823-35. doi: 10.1002/hep.21358.
- Background: PubMed 20392703Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
- Individual participant dataSharing planned: Undecided
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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.
Alberto Meyer, PhD principal investigator
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis and Sarcopenia, run by University of Sao Paulo at 1 site in Brazil.
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 2 inclusion and 3 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 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
Prevalence of Sarcopenia (time frame: Through study completion (an average of 1 year)). The study lists 2 primary outcomes in all. 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 NCT03458845, which also lists 4 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 27 Apr 2021.