Liver CirrhosisNCT03995251
Efficacy and Safety of Testosterone Therapy in Improving Sarcopenia in Men With Cirrhosis.
A study testing Testosterone Supplementation, Standard Medical Treatment and Exercise in people with Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Testosterone Supplementation, Standard Medical Treatment and Exercise
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 4 Jul 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men with cirrhosis of any etiology
- Sarcopenia
- CTP 6-12
Who cannot join
- Hepatocellular carcinoma
- Other known malignancy,
- CTP > 12
- Acute liver injury
- Prostate disease,
- Known hypersensitivity to testosterone therapy,
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- 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.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: 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.
- Conditions
- Liver Cirrhosis
- Being tested
- Testosterone Supplementation, Standard Medical Treatment, Exercise
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone SupplementationDrug
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 TreatmentDrug
Standard Medical Treatment
ExerciseOther
Exercise
| Study group | Role | What they receive |
|---|---|---|
| Standard Medical Treatment +Intramuscular Testosterone + Exerc | Experimental | 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 Receives: Drug: Testosterone Supplementation; Drug: Standard Medical Treatment; Other: Exercise |
| Standard Medical Treatment+Exercise | Active comparator | Standard Medical Treatment +Exercise Receives: Drug: Standard Medical Treatment; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in Lean Appendicular Muscle Mass by more than 10% in both groups
Measured: 24 weeks
Secondary outcomes (12)
Improvement by 10 % in Hand Grip strength in both groups
Measured: 24 weeks
Improvement by 10 % in6 minute walk distance in both groups
Measured: 24 weeks
Improvement by 10 % in the increased bone and muscle mass in both groups
Measured: 24 weeks
Improvement by 10 % L3 Skeletal Muscle Index in both groups.
Measured: 24 weeks
Improvement by 10 % in serum ammonia levels in both groups
Measured: 24 weeks
Improvement by 10 % in muscle fibres on Biopsy in both groups •
Measured: 24 weeks
Reduction in Myostatin level in both groups
Measured: 24 weeks
Improvement in MELD scores in both groups
Measured: 24 weeks
Decrease in mortality over 6 months in both groups
Measured: 24 weeks
Changes in HBA1C level in both groups
Measured: 24 weeks
Reduction in requirement of hospital admissions in both groups
Measured: 24 weeks
Decrease in TNF alpha levels in both groups
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start4 Jul 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995251
- Sponsor's protocol ID
- ILBS-Cirrhosis-21
- Status last verified
- Jun 2019
- First submitted
- 19 Jun 2019
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Testosterone Therapy in Improving Sarcopenia in Men With Cirrhosis a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03995251
- Acronym / sponsor ID
- ILBS-Cirrhosis-21
- Conditions
- Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 24 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Medical Treatment +Intramuscular Testosterone + Exerc | Experimental | Drug: Testosterone Supplementation, Drug: Standard Medical Treatment, Other: ExerciseIntramuscular 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 | Drug: Standard Medical Treatment, Other: ExerciseStandard Medical Treatment +Exercise |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men with cirrhosis of any etiology
- Sarcopenia
- CTP 6-12
Key exclusion criteria (14 listed)
- Hepatocellular carcinoma
- Other known malignancy,
- CTP > 12
- Acute liver injury
- Prostate disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone SupplementationIntramuscular 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 |
| Standard Medical TreatmentStandard Medical Treatment | Drug | Standard Medical Treatment +Intramuscular Testosterone + Exerc, Standard Medical Treatment+Exercise |
| ExerciseExercise | Other | Standard Medical Treatment +Intramuscular Testosterone + Exerc, Standard Medical Treatment+Exercise |
Primary outcome
Increase in Lean Appendicular Muscle Mass by more than 10% in both groups
Time frame: 24 weeks
12 secondary outcomes
Improvement by 10 % in Hand Grip strength in both groups
Time frame: 24 weeks
Improvement by 10 % in6 minute walk distance in both groups
Time frame: 24 weeks
Improvement by 10 % in the increased bone and muscle mass in both groups
Time frame: 24 weeks
Improvement by 10 % L3 Skeletal Muscle Index in both groups.
Time frame: 24 weeks
Improvement by 10 % in serum ammonia levels in both groups
Time frame: 24 weeks
Improvement by 10 % in muscle fibres on Biopsy in both groups •
Time frame: 24 weeks
Reduction in Myostatin level in both groups
Time frame: 24 weeks
Improvement in MELD scores in both groups
Time frame: 24 weeks
Decrease in mortality over 6 months in both groups
Time frame: 24 weeks
Changes in HBA1C level in both groups
Time frame: 24 weeks
Reduction in requirement of hospital admissions in both groups
Time frame: 24 weeks
Decrease in TNF alpha levels in both groups
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Testosterone Supplementation, Standard Medical Treatment and Exercise in people with Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Shushrut Singh, MD (01146300000, drsushrut20@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in Lean Appendicular Muscle Mass by more than 10% in both groups (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.