Effect of venesection on insulin resistance and oxidative stress in people with non-alcoholic fatty liver disease.

Not Applicable

Completed

• Conditions: on-alcoholic fatty liver disease (NAFLD); Hepatic steatosis; Iron overload; Insulin resistance; Non-alcoholic fatty liver disease (NAFLD); Metabolic and Endocrine - Other metabolic disorders; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12610000868088
• Lead Sponsor: Raine Medical Research Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Abdominal ultrasound demonstrated hepatic steatosis within three months of study entry.

Exclusion Criteria

Unable to provide informed consent, Ischaemic heart disease. Anaemia, pregnancy or lactation. Ferritin <50ug/L. Venesection in the last 12 months prior to study entry. Other causes of liver disease: positive hepatitis B serology, positive hepatitis C serology, auto-antibodies, alpha-one anti-trypsin level and ceruloplasmin. Acute or chronic inflammatory conditions. Hereditary haemochromatosis (C282Y/C282Y or C282Y/H63D, HFE gene mutation). Alcohol consumption >20 grams/day for males or >10 grams/day for females. Secondary causes of NAFLD (corticostearoids, gastro-intestinal bypass). Use of anti-oxidants (vitamin E or C) or anti-Tumor Necrosis Factor (TNF) agents (pentocifylline). Poor glycaemic control diabetics-glycated haemoglobin >8% (HbA1c>8%). Decompensated cirrhosis International Normalised Ratio (INR>1.3, albumin >35mg/dl or bilirubin >20 mmol/L or ascites or hepatic encephalopathy. Malignancy (excluding basal cell or squamous cell skin cnacers)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in hepatic Steatosis and a reduction of quantitative liver iron load by using Magnetic Resonance Imaging-Ferriscan (MRI-Ferriscan ), in participants with non-alcoholic fatty liver disease.[End of treatment (6 months)]

Secondary Outcome Measures

Name	Time	Method
Improvement in insulin resistance by Homeostasis Model Assessment (HOMA).[End of treatmnent (6 months)<br><br>Measured with fasting blood test.];Biomarkers of oxidative stress[End of treatment (6 months)<br><br>Measured with Fasting blood test];Serum hepcidin level[End of treatment (6 months)<br><br>Measured with Fasting blood test];Serum adipocytokine level[End of treatment (6 months)<br><br>Measured with Fasting blood test]