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

NCT05157308 | Unknown DMC

• 1 other identifier: CIRR
• Study Type: observational
• Target: 385
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (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

  12 months

Secondary Outcomes (1)

• To determine the prevalence of sarcopenia and myosteatosis in patients with cirrhosis

  12 months

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology/AIG Hospitals

Hyderabad, Telangana, 500082, India

RECRUITING

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mithun Dr Sharma, MBBS MD DM

  Asian Institute of Gastroenterology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Subhankar Dr Godbole, MBBS MD

CONTACT

9420562114; shubhu1308@gmail.com

Rajesh Mr Goud, M.Pharma, MBA

CONTACT

9705053550; rajeshgoud761@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 15, 2021
• Study Start: March 10, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 25, 2021
• Last Updated: December 15, 2021

Record last verified: 2021-11

Locations

IN (1)