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Trial record 43 of 390 for:    Recruiting, Not yet recruiting, Available Studies | Cirrhosis

Efficacy and Safety of Testosterone Therapy in Improving Sarcopenia in Men With Cirrhosis.

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ClinicalTrials.gov Identifier: NCT03995251
Recruitment Status : Not yet recruiting
First Posted : June 24, 2019
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Brief Summary:

Serum testosterone is reduced in up to 90% of men with cirrhosis. Sarcopenia is similarly common in cirrhosis, with an estimated prevalence of 40-70%. This prevalence appears to be greater in men, at 50-70%, as compared to 20% in women. Both low testosterone and sarcopenia have been associated with increased mortality in men with cirrhosis, independent of the Model for End-stage Liver Disease (MELD) score. Reversal of sarcopenia in an observational cohort has been associated with improved survival and thus it is logical to anticipate a mortality-benefit if we can treat sarcopenia in cirrhosis. However, there are currently no interventions supported by randomised controlled data to increase muscle mass in this population. Testosterone is known to increase muscle mass and reduce body fat in both hypogonadal and eugonadal men but it cannot be assumed that the same is true in cirrhosis, due to multiple other factors contributing to the pathogenesis of sarcopenia in this population.

Previous studies investigating the potential therapeutic effects of testosterone therapy in men with cirrhosis have been limited by such issues as inclusion of women and eugonadal men, variable follow-up durations, and inappropriate drug delivery such as oral administration, with inconclusive findings. A Cochrane review of testosterone therapy in men with liver disease included a high proportion of non-cirrhotic subjects with alcoholic hepatitis who ceased alcohol ingestion during the study period, and thus the failure to identify benefit is uninterpretable. Previous studies have not examined effects on muscle mass, which has only relatively recently been identified as an important prognostic factor in cirrhosis.

We hypothesized that testosterone treatment can improve muscle mass in men with cirrhosis and low testosterone levels, and therefore conducted a randomized placebo-controlled trial of appropriately delivered intramuscular testosterone confined to men with established cirrhosis and low testosterone levels, to examine the effects of testosterone in this population.


Condition or disease Intervention/treatment Phase
Liver Cirrhosis Drug: Testosterone Supplementation Drug: Standard Medical Treatment Other: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Testosterone Therapy in Improving Sarcopenia in Men With Cirrhosis a Randomized Controlled Trial
Estimated Study Start Date : June 30, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

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: 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

Drug: Standard Medical Treatment
Standard Medical Treatment

Other: Exercise
Exercise

Active Comparator: Standard Medical Treatment+Exercise
Standard Medical Treatment +Exercise
Drug: Standard Medical Treatment
Standard Medical Treatment

Other: Exercise
Exercise




Primary Outcome Measures :
  1. Increase in Lean Appendicular Muscle Mass by more than 10% in both groups [ Time Frame: 24 weeks ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Males only
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995251


Contacts
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Contact: Dr Shushrut Singh, MD 01146300000 drsushrut20@gmail.com

Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India

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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT03995251     History of Changes
Other Study ID Numbers: ILBS-Cirrhosis-21
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Sarcopenia
Pathologic Processes
Liver Diseases
Digestive System Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents