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.
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.
India1 site, 1 recruiting
- Recruiting
Asian Institute of Gastroenterology/AIG Hospitals
Hyderabad, Telangana, 500082
Dr Mohan Ramchandani, MBBS MD DM, 04023378888 ext. 802, ramchandanimohan@gmail.com
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 -
- 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.
- 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.
- 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.
- 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-
- 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.
- 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.
- 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.
- 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.
- Short physical performance battery - which consists of timed repeated chair stands, balance testing, and a timed 13-ft walk
- 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.
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)
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.
- First posted15 Dec 2021
- Study start10 Mar 2020
- Primary completion1 Dec 2021
- Study completion25 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- Mithun Dr Sharma, MBBS MD DM, Principal investigator, Asian Institute of Gastroenterology, India
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross Sectional Study for Determining Prevalence of Sarcopenia and Myosteatosis in Cirrhotic Patients and to Study the Association Between Imaging and Clinical Parameters
- ClinicalTrials.gov ID
- NCT05157308
- Acronym / sponsor ID
- Myo / CIRR
- Conditions
- Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 25 Dec 2021 (estimated)
- First posted
- 15 Dec 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.
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.
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.
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 -
- 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.
- 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.
- 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.
- 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-
- 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.
- 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.
- 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.
- 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.
- Short physical performance battery - which consists of timed repeated chair stands, balance testing, and a timed 13-ft walk
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sample size required is 385 patients with 80% power and 0.05 type 1 error.
Key inclusion criteria (2 listed)
- Adult patients of cirrhosis Between 18 yrs to 70 yrs attending the liver clinic of the Institute
- Those giving written informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
1 secondary outcome
To determine the prevalence of sarcopenia and myosteatosis in patients with cirrhosis
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
Related trials for Cirrhosis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
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.
Mithun Dr Sharma, MBBS MD DM principal investigator
Asian Institute of Gastroenterology, India
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, 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.