Efficacy and Safety of Testosterone Therapy in Improving Sarcopenia in Men With Cirrhosis.
Schlüsselwörter
Abstrakt
Termine
| Zuletzt überprüft: | 05/31/2019 |
| Zuerst eingereicht: | 06/18/2019 |
| Geschätzte Einschreibung eingereicht: | 06/18/2019 |
| Zuerst veröffentlicht: | 06/23/2019 |
| Letztes eingereichtes Update: | 08/19/2019 |
| Letztes Update veröffentlicht: | 08/20/2019 |
| Tatsächliches Startdatum der Studie: | 07/03/2019 |
| Geschätztes primäres Abschlussdatum: | 06/29/2020 |
| Voraussichtliches Abschlussdatum der Studie: | 06/29/2020 |
Zustand oder Krankheit
Intervention / Behandlung
Drug: Standard Medical Treatment +Intramuscular Testosterone + Exerc
Drug: Standard Medical Treatment
Other: Exercise
Phase
Armgruppen
| Arm | Intervention / Behandlung |
|---|---|
| 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 |
Zulassungskriterien
| Altersberechtigt für das Studium | 18 Years Zu 18 Years |
| Studienberechtigte Geschlechter | All |
| Akzeptiert gesunde Freiwillige | Ja |
| Kriterien | 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. |
Ergebnis
Primäre Ergebnismaße
1. Increase in Lean Appendicular Muscle Mass by more than 10% in both groups [24 weeks]
Sekundäre Ergebnismaße
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]
