Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 51 of 66 for:    strength | ( Map: India )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03995251
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Brief 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 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.


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

Layout table for study information
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
Actual Study Start Date : July 4, 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 ]

Secondary Outcome Measures :
  1. Improvement by 10 % in Hand Grip strength in both groups [ Time Frame: 24 weeks ]
  2. Improvement by 10 % in6 minute walk distance in both groups [ Time Frame: 24 weeks ]
  3. Improvement by 10 % in the increased bone and muscle mass in both groups [ Time Frame: 24 weeks ]
  4. Improvement by 10 % L3 Skeletal Muscle Index in both groups. [ Time Frame: 24 weeks ]
  5. Improvement by 10 % in serum ammonia levels in both groups [ Time Frame: 24 weeks ]
  6. Improvement by 10 % in muscle fibres on Biopsy in both groups • [ Time Frame: 24 weeks ]
  7. Reduction in Myostatin level in both groups [ Time Frame: 24 weeks ]
  8. Improvement in MELD scores in both groups [ Time Frame: 24 weeks ]
  9. Decrease in mortality over 6 months in both groups [ Time Frame: 24 weeks ]
  10. Changes in HBA1C level in both groups [ Time Frame: 24 weeks ]
  11. Reduction in requirement of hospital admissions in both groups [ Time Frame: 24 weeks ]
  12. Decrease in TNF alpha levels in both groups [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Layout table for location contacts
Contact: Dr Shushrut Singh, MD 01146300000 drsushrut20@gmail.com

Locations
Layout table for location information
India
Institute of Liver & Biliary Sciences Recruiting
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India

Layout table for additonal information
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: August 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Cirrhosis
Sarcopenia
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents