Efficacy and Safety of Testosterone Therapy in Improving Sarcopenia in Men With Cirrhosis.
NCT ID: NCT03995251
Last Updated: 2019-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2019-07-04
2020-06-30
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard Medical Treatment +Intramuscular Testosterone + Exerc
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
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
Standard Medical Treatment
Standard Medical Treatment
Exercise
Exercise
Standard Medical Treatment+Exercise
Standard Medical Treatment +Exercise
Standard Medical Treatment
Standard Medical Treatment
Exercise
Exercise
Interventions
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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
Standard Medical Treatment
Standard Medical Treatment
Exercise
Exercise
Eligibility Criteria
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Inclusion Criteria
* Sarcopenia
* CTP 6-12
Exclusion Criteria
* 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.
18 Years
55 Years
ALL
No
Sponsors
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Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
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Locations
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Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Countries
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Central Contacts
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Other Identifiers
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ILBS-Cirrhosis-21
Identifier Type: -
Identifier Source: org_study_id
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