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

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Delhi
      • New Delhi, Delhi, India, 110070
        • Recruiting
        • Institute of Liver & Biliary Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 4, 2019

Primary Completion (ANTICIPATED)

June 30, 2020

Study Completion (ANTICIPATED)

June 30, 2020

Study Registration Dates

First Submitted

June 19, 2019

First Submitted That Met QC Criteria

June 19, 2019

First Posted (ACTUAL)

June 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 21, 2019

Last Update Submitted That Met QC Criteria

August 20, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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