Clinical trial NCT03995251: Efficacy and Safety of Testosterone Therapy in Improving Sarcopenia in Men With Cirrhosis.
Official title: Efficacy and Safety of Testosterone Therapy in Improving Sarcopenia in Men With Cirrhosis a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Increase in Lean Appendicular Muscle Mass by more than 10% in both groups
timeFrame: 24 weeks
Secondary outcomes:
measure: Improvement by 10 % in Hand Grip strength in both groups
timeFrame: 24 weeks
measure: Improvement by 10 % in6 minute walk distance in both groups
timeFrame: 24 weeks
measure: Improvement by 10 % in the increased bone and muscle mass in both groups
timeFrame: 24 weeks
measure: Improvement by 10 % L3 Skeletal Muscle Index in both groups.
timeFrame: 24 weeks
measure: Improvement by 10 % in serum ammonia levels in both groups
timeFrame: 24 weeks
measure: Improvement by 10 % in muscle fibres on Biopsy in both groups •
timeFrame: 24 weeks
measure: Reduction in Myostatin level in both groups
timeFrame: 24 weeks
measure: Improvement in MELD scores in both groups
timeFrame: 24 weeks
measure: Decrease in mortality over 6 months in both groups
timeFrame: 24 weeks
measure: Changes in HBA1C level in both groups
timeFrame: 24 weeks
measure: Reduction in requirement of hospital admissions in both groups
timeFrame: 24 weeks
measure: Decrease in TNF alpha levels in both groups
timeFrame: 24 weeks
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
References: