| Trial ID: | L0747 |
| Source ID: | ACTRN12619000701123
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| Associated Drug: |
Testosterone Undecanoate
|
| Title: |
Testosterone Undecanoate for the treatment of non alcoholic fatty liver disease (TNT) trial
|
| Acronym: |
--
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| Status: |
Not Recruiting
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| Study Results: |
No Results Available
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| Results: |
--
|
| Conditions: |
Non-alcoholic fatty liver disease;Testosterone deficiency; <br>Non-alcoholic fatty liver disease <br>Testosterone deficiency;Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
|
| Interventions: |
Patients will receive either 1000mg of testosterone undecanoate in a 4mL oily solution or a matching oil-based placebo of the same volume via intramuscular injection into the gluteal muscle by experienced nursing staff. Drug administration will occur at
|
| Outcome Measures: |
Percentage change in hepatic steatosis as quantified by magnetic resonance imaging proton fat fraction (MRI-PDFF).[12 months]Change in liver fibrosis estimates by Fibroscan, FIB-4, NAFLD fibrosis score and MRI cT1 by Perspectum Diagnostics Liver MultiScan[12 months];Change in serum ALT [12 months];Change in insulin resistance as measured by the HOMA-IR[12 months];Change in body composition as measured by a composite of lean mass, fat mass and visceral fat by dual energy x-ray absorptiometry[12 months];Change in muscle strength as measured by Handgrip strength[12 months];Change in health-related quality of life as measured by the short form-36 questionnaire (SF36) [12 months];Change in serum total cholesterol level[12 months];Change in body mass index (in meters per kilogram squared) as measured using a stadiometer and digital scales[12 months];Change in fasting blood glucose level[12 months];Change in HbA1c level as measured in mmol/mol by serum assay[12 months];Change in health-related quality of life as measured by the Androgen Deficiency in the Ageing Male (ADAM) questionnaire[12 months];Change in serum LDL level[12 months];Change in serum HDL level[12 months];Change in serum triglyceride level[12 months];Change in waist circumference (cm)[12 months]
|
| Sponsor/Collaborators: |
Austin Health
|
| Gender: |
Male
|
| Age: |
18 Years75 Years
|
| Phases: |
Phase 3
|
| Enrollment: |
120
|
| Study Type: |
Interventional
|
| Study Designs: |
Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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| Start Date: |
09/05/2019
|
| Completion Date: |
--
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| Results First Posted: |
--
|
| Last Update Posted: |
15 July 2019
|
| Locations: |
Australia
|
| URL: |
https://anzctr.org.au/ACTRN12619000701123.aspx
|
