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AzTrials

CirrhosisMyoNCT05157308

A Cross Sectional Study for Determining Prevalence of Sarcopenia and Myosteatosis in Cirrhotic Patients and to Study the Association Between Imaging and Clinical Parameters

An observational study of Cirrhosis, run by Asian Institute of Gastroenterology, India at 1 site in India.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Cirrhosis is associated with a wide variety of metabolic changes in the body. Ascites, hepatic encephalopathy, variceal bleeding, renal dysfunction, and hepatocellular carcinoma are the most widely recognised complications in cirrhosis. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Cirrhosis
How many people
385 participants
Where
1 siteIndia
Study dates
10 Mar 2020to 25 Dec 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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The sample size required is 385 patients with 80% power and 0.05 type 1 error.

Who may be able to join

  • Adult patients of cirrhosis Between 18 yrs to 70 yrs attending the liver clinic of the Institute
  • Those giving written informed consent

Who cannot join

  • Pregnancy or breast feeding
  • Patients with known neurological disorders or musculoskeletal disorders which can hamper the performance of physical tests
  • Patients with history of neoplasia
  • Patients who are unable to understand study protocol or not willing for participation

Trial locations and contacts

1 site in 1 country.

Subhankar Dr Godbole, MBBS MD contact

9420562114

shubhu1308@gmail.com

Rajesh Mr Goud, M.Pharma, MBA contact

9705053550

rajeshgoud761@gmail.com

India1 site, 1 recruiting
  • Asian Institute of Gastroenterology/AIG Hospitals

    Hyderabad, Telangana, 500082

    Dr Mohan Ramchandani, MBBS MD DM, 04023378888 ext. 802, ramchandanimohan@gmail.com

    Recruiting

Other trials in India

About this study

Cirrhosis is associated with a wide variety of metabolic changes in the body. Ascites, hepatic encephalopathy, variceal bleeding, renal dysfunction, and hepatocellular carcinoma are the most widely recognised complications in cirrhosis. Malnutrition and muscle wasting (sarcopenia) constitute common complications, which are generally overlooked, but which negatively impact the survival, quality of life, and response to stressors like infections, sepsis and surgery in cirrhotic patients.

Cirrhotic patients with sarcopenia and myosteatosis have a higher risk of overt hepatic encephalopathy and hyperammonemia.1 It has also been shown that the patients with sarcopenia have a lower overall survival than those without sarcopenia.

Read more

The aim of the current study is to study the prevalence of myosteatosis and sarcopenia in cirrhotic patients, and to compare the clinical and anthropometric parameters for sarcopenia and myosteatosis to that of imaging parameters (CT based diagnosis).

We hypothesize that myosteatosis and sarcopenia can be estimated better with the use of CT scan as compared with clinical assessment and hence, may help in early diagnosis of these conditions.

Read the detailed description

All the patients of liver cirrhosis who attend the Liver clinic of the hospital will undergo a thorough history and examination. After strict inclusion-exclusion criteria patients will be included in the study. All routine investigations required to establish the etiology of cirrhosis and to evaluate the stage of cirrhosis (Child-Turcotte-Pugh status and MELD score) would be done.

The patient will be assessed for the following anthropometric measurements -

  1. Body mass index (BMI) will be calculated. In patients with Ascites- Dry body weight (kg) will be taken by- Post-paracentesis weight (kg) recorded before fluid retention (if available). OR Subtracting a percentage of weight based upon the severity of ascites (Mild Ascites- 5%, Moderate- 10%, Severe- 15%) with an additional 5% subtracted if bilateral pedal oedema is present.
  2. Mid- arm circumference (MUAC) - is the circumference of the left upper arm, measured at the mid-point between the tip of the shoulder and the tip of the elbow (olecranon process and the acromium). Normal value is 29.3 in males and 28.5 mm in females.
  3. Triceps Skin fold thickness - assessed in the mid arm using skin fold callipers. Normal values in adults are usually 12.5 mm in males and 16.5 mm in female.
  4. Mid-arm Muscle circumference (MAMC) - defined as (mid arm circumference - triceps skin fold) x 0.314. Normal values in are 25.3 mm and 23.2 mm in adult males and females respectively.

The patients will be assessed for the indicators of muscle strength by-

  1. 6 min walk Test - It measures the distance that patients can quickly walk in a flat, hard surface within 6 minute. Values > 300 m in 6 min is considered normal, while < or equal to 300 is considered low endurance while < 250m indicates frailty.
  2. Balancing test - It is measured as the number of seconds that the subject can balance in three positions (feet placed side-to-side, semi-tandem, and tandem) for a maximum of 10 seconds each. The duration is recorded for each.
  3. Five times sit to stand test - The subject is to sit in the chair with arms crossed over his/her chest and then to stand up as quickly as possible safely, five times without using his/her arms. Normal person should be able to do it within 12 seconds.
  4. Hand Grip test - It is a function of skeletal muscle contractile strength. It would be tested using a hand held dynamometer and the average of three readings the subject's dominant hand would be taken. The same would be compared with the normative data for the age and sex of the patient.
  5. Short physical performance battery - which consists of timed repeated chair stands, balance testing, and a timed 13-ft walk
  6. Liver frailty index - calculated based upon HG, and balancing test.

After the anthropometric and bedside maneuvers, patient will be subjected to plain Computed tomographic (CT) scan of abdomen. CT image analysis at the L3 vertebra is almost universally recognised as a specific method to quantify muscle loss. It will be done to assess the degree of sarcopenia and myosteatosis as per the criteria.

  • Total cross sectional area cm2 of abdominal skeletal muscle normalized to height = skeletal muscle index ( cm2/m2)
  • Cut off for sarcopenia: 50 cm2/m2 (male) and 39 cm2/m2 (Female) It has been established to have an independent association with pooled transplantation mortality - HR : 1.84 independent of MELD.
  • Cut-off for myosteatosis will be taken as Skeletal muscle radiation attenuation (SM-RA) <41 HU for patients with a body mass index [BMI] up to 24.9 kg/m2 and <33 HU for patients with a BMI ≥25 kg/m2.
Conditions
Cirrhosis
Medical subject headings
Fibrosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare the clinical assessment for sarcopenia (by anthropometric methods and muscle strength indicators) to that of imaging based assessment (CT based assessment)

    The patient will be assessed for the following anthropometric measurements -2. Mid- arm circumference, Triceps Skin fold thickness (width in cms), Mid-arm Muscle circumference

    Measured: 12 months

Secondary outcomes (1)
  1. To determine the prevalence of sarcopenia and myosteatosis in patients with cirrhosis

    The patients will be assessed for the indicators of muscle strength by 6 min walk Test (distance in metres), 2. Balancing test (height in cms) ,Five times sit to stand test

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2021
  2. Study start10 Mar 2020
  3. Primary completion1 Dec 2021
  4. Study completion25 Dec 2021 (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 only
Time perspective
Retrospective
Enrolment
385 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05157308
Sponsor's protocol ID
CIRR
Acronym
Myo
Status last verified
Nov 2021
First submitted
29 Nov 2021
Last updated
15 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cirrhosis, run by Asian Institute of Gastroenterology, India at 1 site in India.

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 15 Dec 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 India. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Subhankar Dr Godbole, MBBS MD (9420562114, shubhu1308@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare the clinical assessment for sarcopenia (by anthropometric methods and muscle strength indicators) to that of imaging based assessment (CT based assessment) (time frame: 12 months). 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 15 Dec 2021.

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