Efficacy and Safety of Testosterone Therapy in Improving Sarcopenia in Men With Cirrhosis.

NCT03995251 | Unknown

• 1 other identifier: ILBS-Cirrhosis-21
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

• Study Population- Patient with cirrhosis with any aetiology with sarcopenia visiting ILBS OPD/IPDs who are willing to visit ILBS gymnasium twice weekly for first month.
• Study Design- A Prospective Randomized Controlled Trial
• Study Period- Study will be conducted at ILBS from April 2019 to Oct 2019
• Sample Size:As shown by Eva Roman et al - in cirhotics with sarcopenia exercise increases mean lean appendicular mass , by 0.38 kg (14 patients, p \< 0.03), and Sinclair et al has shown testosterone (22 patients, p \<0.05)) to increase mean Appendicular lean mass by +1.69 kg - for 10% increase in APLM
• we need to enroll 40 patients in each arm, and considering a los to follow up approx.10% , will require minimum 44 patients in each arm
• We will therefore enroll and randomize 100 patients with 50 in each arm. Intervention - Testosterone Supplementation - Intramuscular Testosterone Undecanoate 1000 Mg (4 ml volume in oily base) will be injected into the upper, outer quadrant of the buttock at 0, 6, 12,16,20, 24 weeks according to manufacturer recommendations. Monitoring and assessment - On every visit patient will be inquired or evaluated for side effects like local site pain or hematoma , hypertension, headache, allergic reactions, acne, nausea , mood swings, pedal edema , breast enlargement and others.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Increase in Lean Appendicular Muscle Mass by more than 10% in both groups

  24 weeks

Secondary Outcomes (12)

• Improvement by 10 % in Hand Grip strength in both groups

  24 weeks

• Improvement by 10 % in6 minute walk distance in both groups

  24 weeks

• Improvement by 10 % in the increased bone and muscle mass in both groups

  24 weeks

• Improvement by 10 % L3 Skeletal Muscle Index in both groups.

  24 weeks

• Improvement by 10 % in serum ammonia levels in both groups

  24 weeks

Study Arms (2)

Standard Medical Treatment +Intramuscular Testosterone + Exerc

EXPERIMENTAL

Intramuscular Testosterone Undecanoate 1000 Mg (4 ml volume in oily base) will be injected into the upper, outer quadrant of the buttock at 0, 6, 12,16,20, 24 weeks according to manufacturer recommendations

Drug: Testosterone Supplementation; Drug: Standard Medical Treatment; Other: Exercise

Standard Medical Treatment+Exercise

ACTIVE COMPARATOR

Standard Medical Treatment +Exercise

Drug: Standard Medical Treatment; Other: Exercise

Interventions

Testosterone Supplementation DRUG

Intramuscular Testosterone Undecanoate 1000 Mg (4 ml volume in oily base) will be injected into the upper, outer quadrant of the buttock at 0, 6, 12,16,20, 24 weeks according to manufacturer recommendations

Standard Medical Treatment +Intramuscular Testosterone + Exerc

Standard Medical Treatment DRUG

Standard Medical Treatment

Standard Medical Treatment +Intramuscular Testosterone + Exerc; Standard Medical Treatment+Exercise

Exercise OTHER

Exercise

Standard Medical Treatment +Intramuscular Testosterone + Exerc; Standard Medical Treatment+Exercise

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Males only
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men with cirrhosis of any etiology
• Sarcopenia
• CTP 6-12

You may not qualify if:

• Hepatocellular carcinoma
• Other known malignancy,
• CTP \> 12
• Acute liver injury
• Prostate disease,
• Known hypersensitivity to testosterone therapy,
• Polycythaemia (haematocrit \>55%),
• Uncontrolled hypertension (\>160/90 mmHg despite treatment),
• Uncontrolled obstructive sleep apnoea,
• Severe renal dysfunction (estimated glomerular filtration rate \<30ml/min)
• Uncontrolled epilepsy, migraine, or significant cardiac insufficiency (New York Heart Association class III or IV or LVEF \< 45-50%.
• CKD (Chronic Kidney Disease) - eGFR (Glomerular Filtration Rate) \<60%
• Platelet count below 30,000 or taking warfarin
• Failure to give consent.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Dr Shushrut Singh, MD

CONTACT

01146300000; drsushrut20@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 24, 2019
• Study Start: July 4, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: August 21, 2019

Record last verified: 2019-06

Locations

IN (1)