Testosterone therapy for the treatment of nonalcoholic fatty liver disease

Phase 3

Recruiting

• Conditions: onalcoholic fatty liver disease; Testosterone deficiency; Nonalcoholic fatty liver disease; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12619000701123
• Lead Sponsor: Austin Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-09
• Last Update Posted: 17 April 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 120

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
11) Contraindications to MRI (non-MRI-compatible pacemaker or other device, severe claustrophobia, inability to breath hold)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage change in hepatic steatosis as quantified by magnetic resonance imaging proton fat fraction (MRI-PDFF).[12 months]