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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 : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Sandeep S Sidhu, Dayanand Medical College and Hospital

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 : July 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
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)
Drug: Placebo
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)




Primary Outcome Measures :
  1. 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)

  2. 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)


Secondary Outcome Measures :
  1. Change in muscle performance [ Time Frame: 3 month ]
    3-month change in muscle performance assessed by change in Gait Velocity (m/min)

  2. 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)

  3. 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

  4. Change in muscle performance [ Time Frame: 3 month ]
    Change in muscle performance assessed by improvement in Chair Stand.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Cirrhosis as diagnosed by clinical, biochemical, radiological or histologic criteria Cirrhosis - Child C class (10 - 15 score)
  2. L3 SMI value < 45.4
  3. Hand Grip Strength < 33.67

Exclusion Criteria:

1. Patients with hepatocellular carcinoma, in hepatic coma, with acquired immunodeficiency syndrome, with renal or pancreatic insufficiency, receiving enteral nutrition or being pregnant,


Information from the National Library of Medicine

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


Contacts
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Contact: Sandeep Singh Sidhu, DM +919814025085 sandeepsidhu1963@gmail.com

Locations
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India
Dyanand Medical College and Hospital Recruiting
Ludhiana, Punjab, India, 141001
Contact: Sandeep Singh Sidhu, MD,DM    +919814025085    sandeepsidhu1963@gmail.com   
Contact: Omesh Goyal, MD,DM    +919914821155    goyalomesh@yahoo.co.in   
Principal Investigator: Sandeep Singh Sidhu, MD,DM         
Sponsors and Collaborators
Dayanand Medical College and Hospital
Investigators
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Principal Investigator: Sandeep s Sidhu, DM Dayanand Medical College and Hospital, Ludhiana, Punjab, India

Publications of Results:

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Responsible Party: Prof. Sandeep S Sidhu, Professor, Dayanand Medical College and Hospital
ClinicalTrials.gov Identifier: NCT03633279     History of Changes
Other Study ID Numbers: SIMM 2018
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Liver Cirrhosis
Sarcopenia
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms