Efficacy and Safety of Testosterone Therapy in Improving Sarcopenia in Men With Cirrhosis.
Keywords
Abstract
Dates
| Last Verified: | 05/31/2019 |
| First Submitted: | 06/18/2019 |
| Estimated Enrollment Submitted: | 06/18/2019 |
| First Posted: | 06/23/2019 |
| Last Update Submitted: | 08/19/2019 |
| Last Update Posted: | 08/20/2019 |
| Actual Study Start Date: | 07/03/2019 |
| Estimated Primary Completion Date: | 06/29/2020 |
| Estimated Study Completion Date: | 06/29/2020 |
Condition or disease
Intervention/treatment
Drug: Standard Medical Treatment +Intramuscular Testosterone + Exerc
Drug: Standard Medical Treatment
Other: Exercise
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: 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 | 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 |
| Active Comparator: Standard Medical Treatment+Exercise Standard Medical Treatment +Exercise |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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. |
Outcome
Primary Outcome Measures
1. Increase in Lean Appendicular Muscle Mass by more than 10% in both groups [24 weeks]
Secondary Outcome Measures
1. Improvement by 10 % in Hand Grip strength in both groups [24 weeks]
2. Improvement by 10 % in6 minute walk distance in both groups [24 weeks]
3. Improvement by 10 % in the increased bone and muscle mass in both groups [24 weeks]
4. Improvement by 10 % L3 Skeletal Muscle Index in both groups. [24 weeks]
5. Improvement by 10 % in serum ammonia levels in both groups [24 weeks]
6. Improvement by 10 % in muscle fibres on Biopsy in both groups • [24 weeks]
7. Reduction in Myostatin level in both groups [24 weeks]
8. Improvement in MELD scores in both groups [24 weeks]
9. Decrease in mortality over 6 months in both groups [24 weeks]
10. Changes in HBA1C level in both groups [24 weeks]
11. Reduction in requirement of hospital admissions in both groups [24 weeks]
12. Decrease in TNF alpha levels in both groups [24 weeks]
