Treatment of Sarcopenia Improves the Muscle Mass and Muscle Strength of Patients With Liver Cirrhosis-Child C

NCT03633279 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: SIMM 2018
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (2)

• Change in CT Skeletal muscle index (cm2/m2)

  Change in CT Skeletal muscle index (cm2/m2) (i.e difference between the baseline and 3 month values)

  3 month

• Change in Hand Grip Strength (Kilograms)

  3-month change in Hand Grip Strength (Kilogram) (calculated as the difference between the baseline and 3-month values obtained by Hand Grip Dynamometer)

  3 month

Secondary Outcomes (4)

• Change in muscle performance

  3 month

• Event-free survival

  3 month

• Change in Quality of life: SF 36 Scale

  3 month

• Change in muscle performance

  3 month

Study Arms (2)

Branched Chain Amino Acid

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Branched chain amino acid DRUG

Branched chain amino acid 10 grams packet (L-Isoleucine (952 Mg), L-Leucine (1904 Mg.), L-Valine(1144 Mg).

Branched Chain Amino Acid

Placebo DRUG

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)

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dayanand Medical College and Hospital: lead

Study Sites (1)

Dayanand Medical College and Hospital

Ludhiana, Punjab, 141001, India

Location

Related Publications (8)

• Kim G, Kang SH, Kim MY, Baik SK. Prognostic value of sarcopenia in patients with liver cirrhosis: A systematic review and meta-analysis. PLoS One. 2017 Oct 24;12(10):e0186990. doi: 10.1371/journal.pone.0186990. eCollection 2017.

  PMID: 29065187 BACKGROUND

• Kim HY, Jang JW. Sarcopenia in the prognosis of cirrhosis: Going beyond the MELD score. World J Gastroenterol. 2015 Jul 7;21(25):7637-47. doi: 10.3748/wjg.v21.i25.7637.

  PMID: 26167066 BACKGROUND

• Wong CH, Weiss D, Sourial N, Karunananthan S, Quail JM, Wolfson C, Bergman H. Frailty and its association with disability and comorbidity in a community-dwelling sample of seniors in Montreal: a cross-sectional study. Aging Clin Exp Res. 2010 Feb;22(1):54-62. doi: 10.1007/BF03324816. Epub 2009 Nov 25.

  PMID: 19940555 BACKGROUND

• Merli M, Lucidi C, Giannelli V, Giusto M, Riggio O, Falcone M, Ridola L, Attili AF, Venditti M. Cirrhotic patients are at risk for health care-associated bacterial infections. Clin Gastroenterol Hepatol. 2010 Nov;8(11):979-85. doi: 10.1016/j.cgh.2010.06.024. Epub 2010 Aug 12.

  PMID: 20621200 BACKGROUND

• Roubenoff R. Sarcopenia: effects on body composition and function. J Gerontol A Biol Sci Med Sci. 2003 Nov;58(11):1012-7. doi: 10.1093/gerona/58.11.m1012.

  PMID: 14630883 BACKGROUND

• Montano-Loza AJ, Meza-Junco J, Prado CM, Lieffers JR, Baracos VE, Bain VG, Sawyer MB. Muscle wasting is associated with mortality in patients with cirrhosis. Clin Gastroenterol Hepatol. 2012 Feb;10(2):166-73, 173.e1. doi: 10.1016/j.cgh.2011.08.028. Epub 2011 Sep 3.

  PMID: 21893129 BACKGROUND

• Dasarathy S, Merli M. Sarcopenia from mechanism to diagnosis and treatment in liver disease. J Hepatol. 2016 Dec;65(6):1232-1244. doi: 10.1016/j.jhep.2016.07.040. Epub 2016 Aug 8.

  PMID: 27515775 BACKGROUND

• Wilson D, Jackson T, Sapey E, Lord JM. Frailty and sarcopenia: The potential role of an aged immune system. Ageing Res Rev. 2017 Jul;36:1-10. doi: 10.1016/j.arr.2017.01.006. Epub 2017 Feb 20.

  PMID: 28223244 BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Amino Acids, Branched-Chain

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Sandeep s Sidhu, DM

  Dayanand Medical College and Hospital, Ludhiana, Punjab, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: August 16, 2018
• Study Start: June 22, 2018
• Primary Completion: January 10, 2024
• Study Completion: September 10, 2025
• Last Updated: June 27, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)