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

Institute of Liver and Biliary Sciences, India

Status: Unknown

Conditions: Liver Cirrhosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03995251

ILBS-Cirrhosis-21

Details and patient eligibility

About

• 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Standard Medical Treatment +Intramuscular Testosterone + Exerc

Experimental group

Description:

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

Treatment:

Other: Exercise

Drug: Standard Medical Treatment

Drug: Testosterone Supplementation

Standard Medical Treatment+Exercise

Active Comparator group

Description:

Standard Medical Treatment +Exercise

Treatment:

Other: Exercise

Drug: Standard Medical Treatment