ACTRN12619000701123
Recruiting
Phase 3
A randomised controlled trial of Testosterone Undecanoate therapy for the treatment of non-alcoholic fatty liver disease (TNT)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Austin Health
- Enrollment
- 120
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Men with estimated hepatic steatosis greater than or equal to 30% by meeting 1 of the following criteria:
- •a. Diffuse increased echogenicity of the liver parenchyma on ultrasound as compared to echogenicity of renal cortex or spleen
- •b. Reduced attenuation on CT scan (less than or equal to 40 Houndsfield units)
- •c. Controlled attenuation parameter on fibroscan above 270dB/m
- •2\) Age 18 to 75 years of age.
- •3\) Plasma total testosterone less than or equal to 12nmol/L or free testosterone less than or equal to 230pmol/L on two occasions.
- •4\) Fibroscan greater than or equal to 7\.0kPa OR ALT greater than or equal to 30u/L, to identify men at risk of progression of liver disease.
Exclusion Criteria
- •1\) Alcohol consumption \>21 units per week \>2 weeks in the last year or \>3 months of the past 5 years to exclude inadvertent inclusion of patients with alcoholic liver disease
- •2\) Other significant cause for liver disease, including autoimmune liver disease, metabolic liver disease such as Wilson’s disease or hereditary haemachromatosis, or viral hepatitis (excluding Hepatitis C virus treated \>12 months ago)
- •3\) Prostate cancer, elevated PSA or abnormal prostate on digital rectal exam
- •4\) Hepatocellular or other active cancer
- •5\) Current or previous (within 12 months) testosterone or androgen deprivation therapy
- •6\) Severe renal impairment (eGFR \<30ml/min)
- •7\) Symptomatic ischaemic heart disease or significant heart failure symptoms (New York Heart Association class III or IV)
- •8\) Uncontrolled hypertension \>160/100mHg
- •9\) Uncontrolled obstructive sleep apnoea
- •10\) Decompensated cirrhosis, as evidence by Child Pugh Score B or C, given risk of death or transplantation within the study period
Outcomes
Primary Outcomes
Not specified
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