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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

  1. st part : Patients with liver cirrhosis will be evaluated for the presence of sarcopenia.
  2. 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
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.

  1. 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.

  1. First posted14 Aug 2018
  2. Study start1 Oct 2018 (estimated)
  3. Primary completion1 Apr 2020 (estimated)
  4. Study completion1 Oct 2020 (estimated)

Resources

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)
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

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.

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