Efficacy and Safety of Testosterone Therapy in Improving Sarcopenia in Men With Cirrhosis a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Increase in Lean Appendicular Muscle Mass by more than 10% in both groups
研究概览
简要总结
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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.
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Study Design- A Prospective Randomized Controlled Trial
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Study Period- Study will be conducted at ILBS from April 2019 to Oct 2019
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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
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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
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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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men with cirrhosis of any etiology
- •Sarcopenia
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Testosterone Supplementation (Drug)
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
干预措施: Standard Medical Treatment (Drug)
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
干预措施: Exercise (Other)
Standard Medical Treatment+Exercise
Standard Medical Treatment +Exercise
干预措施: Standard Medical Treatment (Drug)
Standard Medical Treatment+Exercise
Standard Medical Treatment +Exercise
干预措施: Exercise (Other)
结局指标
主要结局
Increase in Lean Appendicular Muscle Mass by more than 10% in both groups
时间窗: 24 weeks
次要结局
- Reduction in requirement of hospital admissions in both groups(24 weeks)
- Decrease in TNF alpha levels 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)
- Improvement by 10 % in muscle fibres on Biopsy in both groups •(24 weeks)
- Reduction in Myostatin level in both groups(24 weeks)
- Improvement in MELD scores in both groups(24 weeks)
- Improvement by 10 % in Hand Grip strength in both groups(24 weeks)
- Changes in HBA1C level in both groups(24 weeks)
- Decrease in mortality over 6 months in both groups(24 weeks)