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

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.

Study Overview

• Status: Recruiting
• Conditions: Cirrhosis

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.

• Study Type: Observational
• Enrollment (Anticipated): 385

Contacts and Locations

• Study Contact: Name: Subhankar Dr Godbole, MBBS MD; Phone Number: 9420562114; Email: shubhu1308@gmail.com
• Study Contact Backup: Name: Rajesh Mr Goud, M.Pharma, MBA; Phone Number: 9705053550; Email: rajeshgoud761@gmail.com

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500082
      • Recruiting
      • Asian institute of Gastroenterology/AIG Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India
• Investigators: Principal Investigator: Mithun Dr Sharma, MBBS MD DM, Asian Institute of Gastroenterology

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2020
• Primary Completion (Actual): December 1, 2021
• Study Completion (Anticipated): December 25, 2021

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: December 11, 2021
• First Posted (Actual): December 15, 2021

Study Record Updates

• Last Update Posted (Actual): December 15, 2021
• Last Update Submitted That Met QC Criteria: December 11, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: CIRR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No