Venesection in iron overload and concurrent non-alcoholic fatty liver disease

Not Applicable

Recruiting

• Conditions: on-alcoholic fatty liver disease; Dysmetabolic iron overload syndrome; Non-alcoholic fatty liver disease; Metabolic and Endocrine - Other metabolic disorders; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12622000143729
• Lead Sponsor: Marie Sinclair

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-27
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Non-alcoholic fatty liver disease evident radiologically (hepatic steatosis on ultrasonography, computed tomography or magnetic resonance of the liver, or controlled attenuation parameter >248 dB/m on transient elastography) and/or histological evidence of steatosis on liver biopsy
- Serum ferritin >600 micrograms/L
- Histological evidence of hepatic iron overload identified by Perl's stain for iron on liver biopsy

Exclusion Criteria

•Anaemia (Hb less than 120 g/L for women, less than 130 g/L for men)
•Hereditary haemochromatosis defined by C282Y homozygosity or C282Y/H63D compound heterozygosity
•Alcohol consumption greater than 140 grams per week for men, or greater than 100 grams per week for women
•Weight loss greater than 5% body weight 6 months prior to study inclusion
•Chronic kidney disease stage 3 or greater, defined by eGFR less than 30 mL/min
•Heart failure with left ventricular ejection fraction less than 40%, or ischaemic heart disease
•Decompensated cirrhosis, defined by Child Pugh class B or C
•Alternate cause of liver disease other than NAFLD
•Concurrent use of steatogenic medications (eg. tamoxifen, methotrexate, amiodarone, prednisolone)
•Inadequate venous access to facilitate regular venesection as assessed by apharesis unit
•HbA1c greater than 10%
•Coagulopathy such that risk of liver biopsy unacceptable
•Pregnancy
•Change in diabetic medication within 3 months
•Those who do not speak English as a first language

Study & Design

• Study Type: Interventional
• Study Design: Not specified