Sarcopenia in Liver CirrhosisNCT03629444
Assessment of Sarcopenia in Patients With Liver Cirrhosis and Its Prognostic Value in Liver Transplant Candidates
An observational study of Sarcopenia in Liver Cirrhosis, run by marwa abdElRazek Ahmed sala.a makhlof.
Trial summary
Sarcopenia is a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength, shown to be prevalent in adults with cancer and common chronic comorbidities such as liver cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sarcopenia in Liver Cirrhosis
- What is being tested?
- ct scan
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 1 Oct 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: First part: total coverage of all elligable patients admitted to the department for 1 year who expected 300 patients with liver cirrhosis (only 50 patients will be done CT abdomen due to financial obstacle). - Second part:13 cases of liver cirrhosis already done liver transplantation in AL Rajhiuneversitiy hospital and any cirrhotic pts will be prerared for liver transplantion within six months.
Who may be able to join
- Patients with liver cirrhosis.
- Age: 18 - 65 years.
Who cannot join
- Cirrhotic patients with:
- Activecomorbid disease e.g. Diabetes mellitus, pulmonary, renal disease (especially .hepatorenal syndrome).
- Malignancy
- Receiving anabolic steroids
About this study
Sarcopenia is a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength, shown to be prevalent in adults with cancer and common chronic comorbidities such as liver cirrhosis.
The EWGSOP identified a grading for Sarcopenia into pre-sarcopenia (decreased muscle mass with normal strength and physical performance), sarcopenia (decreased muscle mass with decreased strength or performance), severe Sarcopenia (decreased muscle mass, strength and performance) .
Read more
Sarcopenia has emerged as an independent predictor of poor prognosis in a variety of clinical conditions.Sarcopenia is clinically important because it can affectthe quality of life of patients with cirrhosis .
Skeletal muscle mass is not only a good indicator of nutrition in patients with cirrhosis, but also has recently been shown to be closely associated with survival prognosis and postoperative complications inHCC.
Combination of sarcopenia and the Model for End-stage Liver Disease (MELD) has been shown to be an excellent model for predicting prognosis in decompensated liver cirrhosis .
Most patients awaiting liver transplantation (LT) are more or less in a state of sarcopenia. Several studies have reported that sarcopenia was associated with worse prognosis.In addition, sarcopenia may be associated with a higher risk of post-transplant infection .
Assessment of sarcopenia in patients with liver cirrhosis:_ The European Working Group on Sarcopenia in Older People recommended that the definition of sarcopenia include not only low muscle mass but also low muscle function . They recommended cutoff values for muscle mass measurements (7.26 kg/m2 for men and 5.5 kg/m2 for women using dual X-ray absorptiometry, and 8.87 kg/m2 for men and 6.42 kg/m2 for women using bioimpedance analysis, handgrip strength (<30 kg for men and <20 kg for women), and usual gait speed (<0.8 m/s).
Aim of the study
- To evaluate sarcopenia in different stages of liver cirrhosis by different diagnostic methods.
- To identify the prognostic value of CT in the diagnosis of sarcopenia .
- To identify effect of sarcopenia inliver transplant candidate.
Patients and methods:
Type of the study:the study is divided into two parts First part: observational descriptive cross sectional study. Second part: follow up of liver transplant candidate group (pre and post liver transplantation) Duration of study: expected duration of the study will be 1.5 years . The 1st part will include all patients admitted to the department for 1 year fulfill inclusion criteria .
2nd part will be 6 ms follow up after liver transplantation. Study population
- st part : Patients with liver cirrhosis will be evaluated for the presence of sarcopenia.
- nd part:
- 13 cases of liver cirrhosis already done liver transplantation in AL Rajhiuneversitiy hospital(which data already recoreded) and any cirrhotic pts will be prerared for liver transplantion within six months.
- Methods At the study entry, all candidates will be subjected to the following parameters (and 3 month after LT for liver transplant candidates only)
- Clinical history
- Clinical examination
- Abdominal ultrasound
- Laboratory investigation:
- Liver function tests
- Complete blood picture,
- Kidney function tests,
- Serum glucose, serum Na+ and K+
- Hepatitis markers (HBsAg, HCV-Ab)
- Calculate: = Child Pugh score (Pugh et al., 1973) and MELD (Wiesner et al., 2003) scores for assessment ofliver cirrhosis.
- Anthropometric measurements:
- Triceps skin fold thickness (TSF) .
- Measure mid-arm circumference (MAC).
- Body mass index
- Hand grip to assess muscle strength
- Gait speed to assess physical performance
- Assessment of sarcopenia using CT scan:
- Assessment of sarcopenia using ultrasound:
- Assessment of sarcopenia using bioimpedance analysis
- Conditions
- Sarcopenia in Liver Cirrhosis
- Being tested
- ct scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ct scanRadiation
all patients will be subjected to CT scan and anthroprometric measurments
What is being measured
The primary outcome is the main question the study is designed to answer.
grading of sarcopenia in liver cirrhosis .
all patients will done CT abdomen with lower limit 38 in female and 53 in male which mean sarcopenia all patients wiill be measure height in cm by stadiometer . all pateints will measure weight in kilograms by weight measuring device. all pateints will be calculated BMI which mean weight\(height)2. with normal range 18.5 to 24.9
Measured: about one and half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start1 Oct 2018 (estimated)
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenia in Liver CirrhosisStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- marwa abdElRazek Ahmed sala.a makhlof
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, marwa abdElRazek Ahmed sala.a makhlof, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629444
- Sponsor's protocol ID
- AssiutU2018
- Status last verified
- Jul 2018
- First submitted
- 22 Jul 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sarcopenia in Patients With Liver Cirrhosis and Its Prognostic Value in Liver Transplant Candidates
- ClinicalTrials.gov ID
- NCT03629444
- Acronym / sponsor ID
- AssiutU2018
- Conditions
- Sarcopenia in Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- marwa abdElRazek Ahmed sala.a makhlofUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 14 Aug 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.
Sarcopenia is a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength, shown to be prevalent in adults with cancer and common chronic comorbidities such as liver cirrhosis.
The EWGSOP identified a grading for Sarcopenia into pre-sarcopenia (decreased muscle mass with normal strength and physical performance), sarcopenia (decreased muscle mass with decreased strength or performance), severe Sarcopenia (decreased muscle mass, strength and performance) .
Sarcopenia has emerged as an independent predictor of poor prognosis in a variety of clinical conditions.Sarcopenia is clinically important because it can affectthe quality of life of patients with cirrhosis .
Skeletal muscle mass is not only a good indicator of nutrition in patients with cirrhosis, but also has recently been shown to be closely associated with survival prognosis and postoperative complications inHCC.
Combination of sarcopenia and the Model for End-stage Liver Disease (MELD) has been shown to be an excellent model for predicting prognosis in decompensated liver cirrhosis .
Most patients awaiting liver transplantation (LT) are more or less in a state of sarcopenia. Several studies have reported that sarcopenia was associated with worse prognosis.In addition, sarcopenia may be associated with a higher risk of post-transplant infection .
Assessment of sarcopenia in patients with liver cirrhosis:_ The European Working Group on Sarcopenia in Older People recommended that the definition of sarcopenia include not only low muscle mass but also low muscle function . They recommended cutoff values for muscle mass measurements (7.26 kg/m2 for men and 5.5 kg/m2 for women using dual X-ray absorptiometry, and 8.87 kg/m2 for men and 6.42 kg/m2 for women using bioimpedance analysis, handgrip strength (<30 kg for men and <20 kg for women), and usual gait speed (<0.8 m/s).
Aim of the study
- To evaluate sarcopenia in different stages of liver cirrhosis by different diagnostic methods.
- To identify the prognostic value of CT in the diagnosis of sarcopenia .
- To identify effect of sarcopenia inliver transplant candidate.
Patients and methods:
Type of the study:the study is divided into two parts First part: observational descriptive cross sectional study. Second part: follow up of liver transplant candidate group (pre and post liver transplantation) Duration of study: expected duration of the study will be 1.5 years . The 1st part will include all patients admitted to the department for 1 year fulfill inclusion criteria .
2nd part will be 6 ms follow up after liver transplantation. Study population
- st part : Patients with liver cirrhosis will be evaluated for the presence of sarcopenia.
- nd part:
- 13 cases of liver cirrhosis already done liver transplantation in AL Rajhiuneversitiy hospital(which data already recoreded) and any cirrhotic pts will be prerared for liver transplantion within six months.
- Methods At the study entry, all candidates will be subjected to the following parameters (and 3 month after LT for liver transplant candidates only)
- Clinical history
- Clinical examination
- Abdominal ultrasound
- Laboratory investigation:
- Liver function tests
- Complete blood picture,
- Kidney function tests,
- Serum glucose, serum Na+ and K+
- Hepatitis markers (HBsAg, HCV-Ab)
- Calculate: = Child Pugh score (Pugh et al., 1973) and MELD (Wiesner et al., 2003) scores for assessment ofliver cirrhosis.
- Anthropometric measurements:
- Triceps skin fold thickness (TSF) .
- Measure mid-arm circumference (MAC).
- Body mass index
- Hand grip to assess muscle strength
- Gait speed to assess physical performance
- Assessment of sarcopenia using CT scan:
- Assessment of sarcopenia using ultrasound:
- Assessment of sarcopenia using bioimpedance analysis
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- First part: total coverage of all elligable patients admitted to the department for 1 year who expected 300 patients with liver cirrhosis (only 50 patients will be done CT abdomen due to financial obstacle). - Second part:13 cases of liver cirrhosis already done liver transplantation in AL Rajhiuneversitiy hospital and any cirrhotic pts will be prerared for liver transplantion within six months.
Key inclusion criteria (2 listed)
- Patients with liver cirrhosis.
- Age: 18 - 65 years.
Key exclusion criteria (4 listed)
- Activecomorbid disease e.g. Diabetes mellitus, pulmonary, renal disease (especially .hepatorenal syndrome).
- Malignancy
- Receiving anabolic steroids
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 |
|---|---|---|
| ct scanall patients will be subjected to CT scan and anthroprometric measurments | Radiation | – |
Primary outcome
grading of sarcopenia in liver cirrhosis .
Time frame: about one and half year
all patients will done CT abdomen with lower limit 38 in female and 53 in male which mean sarcopenia all patients wiill be measure height in cm by stadiometer . all pateints will measure weight in kilograms by weight measuring device. all pateints will be calculated BMI which mean weight\(height)2. with normal range 18.5 to 24.9
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia in Liver Cirrhosis, run by marwa abdElRazek Ahmed sala.a makhlof.
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 4 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: status not confirmed, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
grading of sarcopenia in liver cirrhosis . (time frame: about one and half year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2018.