- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03995251
Efficacy and Safety of Testosterone Therapy in Improving Sarcopenia in Men With Cirrhosis.
Efficacy and Safety of Testosterone Therapy in Improving Sarcopenia in Men With Cirrhosis a Randomized Controlled Trial
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Delhi
-
New Delhi, Delhi, India, 110070
- Recruiting
- Institute of Liver & Biliary Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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
|
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
Exercise
|
ACTIVE_COMPARATOR: Standard Medical Treatment+Exercise
Standard Medical Treatment +Exercise
|
Standard Medical Treatment
Exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Increase in Lean Appendicular Muscle Mass by more than 10% in both groups
Time Frame: 24 weeks
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement by 10 % in Hand Grip strength in both groups
Time Frame: 24 weeks
|
24 weeks
|
Improvement by 10 % in6 minute walk distance in both groups
Time Frame: 24 weeks
|
24 weeks
|
Improvement by 10 % in the increased bone and muscle mass in both groups
Time Frame: 24 weeks
|
24 weeks
|
Improvement by 10 % L3 Skeletal Muscle Index in both groups.
Time Frame: 24 weeks
|
24 weeks
|
Improvement by 10 % in serum ammonia levels in both groups
Time Frame: 24 weeks
|
24 weeks
|
Improvement by 10 % in muscle fibres on Biopsy in both groups •
Time Frame: 24 weeks
|
24 weeks
|
Reduction in Myostatin level in both groups
Time Frame: 24 weeks
|
24 weeks
|
Improvement in MELD scores in both groups
Time Frame: 24 weeks
|
24 weeks
|
Decrease in mortality over 6 months in both groups
Time Frame: 24 weeks
|
24 weeks
|
Changes in HBA1C level in both groups
Time Frame: 24 weeks
|
24 weeks
|
Reduction in requirement of hospital admissions in both groups
Time Frame: 24 weeks
|
24 weeks
|
Decrease in TNF alpha levels in both groups
Time Frame: 24 weeks
|
24 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Liver Diseases
- Neuromuscular Manifestations
- Pathological Conditions, Anatomical
- Muscular Atrophy
- Atrophy
- Fibrosis
- Liver Cirrhosis
- Sarcopenia
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Androgens
- Testosterone
Other Study ID Numbers
- ILBS-Cirrhosis-21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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