Sarcopenia Improves the Muscle Mass and Muscle Strength of Patients With Liver Cirrhosis-Child C
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|ClinicalTrials.gov Identifier: NCT03633279|
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : October 28, 2019
Sarcopenia is defined as loss of skeletal muscle mass. In cirrhosis, due to impaired urea genesis and decreased hepatic ammonia disposal, the skeletal muscle functions as a metabolic partner for the liver. The proportion of patients with sarcopenia is higher in those with alcoholic liver cirrhosis (80%) compared to cirrhosis due to other etiologies (31%-71%).
Sarcopenia is prevalent in > 50% patients with Child C cirrhosis. Sarcopenia increases the risk for severe infections in patients with cirrhosis. Adequate amino acid supply is needed for appropriate antibody and cytokine responses, that is impaired when skeletal muscle mass. The sepsis-related mortality rates in patients with and without sarcopenia are 22% and 8%, respectively (P = 0.02). In patients with liver cirrhosis is protein-calorie malnutrition, leading to severe consequences to the general state and clinical evolution of the patient.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cirrhoses||Drug: Branched chain amino acid Drug: Placebo||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Treatment of Sarcopenia Improves the Muscle Mass and Muscle Strength of Patients With Liver Cirrhosis- Child C: A Randomized Double Blind Control Trial|
|Actual Study Start Date :||June 22, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Branched Chain Amino Acid
Branched Chain amino acid 10 grams packet (L-Isoleucine (952 Mg), L-Leucine (1904 Mg.), L-Valine(1144 Mg). one packet at 6pm and two at 9pm.
Drug: Branched chain amino acid
Branched chain amino acid 10 grams packet (L-Isoleucine (952 Mg), L-Leucine (1904 Mg.), L-Valine(1144 Mg).
Placebo Comparator: Placebo
Equinitrogenous amount of lactoalbumin 2.1 grams, and equicaloric amount with 4.0 g saccharose and 3.0 g mannitol for a total of 33.6 kcal/packet.(one packet at 6pm and two at 9pm)
an equinitrogenous amount of lactoalbumin 2.1 grams, and equicaloric amount with 4.0 g saccharose and 3.0 g mannitol for a total of 33.6 kcal/packet.(one packet at 6pm and two at 9pm)
- Change in CT Skeletal muscle index (cm2/m2) [ Time Frame: 3 month ]Change in CT Skeletal muscle index (cm2/m2) (i.e difference between the baseline and 3 month values)
- Change in Hand Grip Strength (Kilograms) [ Time Frame: 3 month ]3-month change in Hand Grip Strength (Kilogram) (calculated as the difference between the baseline and 3-month values obtained by Hand Grip Dynamometer)
- Change in muscle performance [ Time Frame: 3 month ]3-month change in muscle performance assessed by change in Gait Velocity (m/min)
- Event-free survival [ Time Frame: 3 month ]3-month event-free survival at 3 months (events including complications of Cirrhosis i.e. Hepatic encephalopathy, Ascites and edema, Variceal Hemorrhage, Spontaneous Bacterial Peritonitis and Hepatorenal Syndrome)
- Change in Quality of life: SF 36 Scale [ Time Frame: 3 month ]Change in health related quality of life measure by Short Form Health Survey (SF 36) QUESTIONNAIRE
- Change in muscle performance [ Time Frame: 3 month ]Change in muscle performance assessed by improvement in Chair Stand.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633279
|Contact: Sandeep Singh Sidhu, DMfirstname.lastname@example.org|
|Dyanand Medical College and Hospital||Recruiting|
|Ludhiana, Punjab, India, 141001|
|Contact: Sandeep Singh Sidhu, MD,DM +919814025085 email@example.com|
|Contact: Omesh Goyal, MD,DM +919914821155 firstname.lastname@example.org|
|Principal Investigator: Sandeep Singh Sidhu, MD,DM|
|Principal Investigator:||Sandeep s Sidhu, DM||Dayanand Medical College and Hospital, Ludhiana, Punjab, India|