A Cross Sectional Study for Determining Prevalence of Sarcopenia and Myosteatosis in Cirrhotic Patients and to Study the Association Between Imaging and Clinical Parameters
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 385
- 试验地点
- 1
- 主要终点
- To compare the clinical assessment for sarcopenia (by anthropometric methods and muscle strength indicators) to that of imaging based assessment (CT based assessment)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients of cirrhosis Between 18 yrs to 70 yrs attending the liver clinic of the Institute
- •Those giving written informed consent
排除标准
- •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
结局指标
主要结局
To compare the clinical assessment for sarcopenia (by anthropometric methods and muscle strength indicators) to that of imaging based assessment (CT based assessment)
时间窗: 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
次要结局
- To determine the prevalence of sarcopenia and myosteatosis in patients with cirrhosis(12 months)
研究者
Mohan Ramchandani
Clinical Professor
Asian Institute of Gastroenterology, India
