Impact of iron on insulin resistance in people with hepatitis associated with non-alcoholic fatty liver disease.

Not Applicable

Completed

• Conditions: on-alcoholic fatty liver disease (NAFLD); non-alcoholic steatohepatitis (NASH); Iron overload; Insulin resistance; Non-alcoholic fatty liver disease (NAFLD); Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12608000448347
• Lead Sponsor: Raines Medical Research Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-09-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

Inclusion Criteria

Biopsy demonstrating NASH within six months of trial entry.

Exclusion Criteria

Unable to provide informed consent
Ischemic heart disease
Anaemia
Pregnancy or lactation
Ferritin <50 ug/L
Venesection in the previous 12 months prior to trial 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 con ditions
Hereditary hemochromatosis (C282Y/C282Y or C282Y/H63D HFE gene mutation)
Alcohol consumption >20 grams/dat for males, >10 grams/day for females
Secondary causes of NAFLD (corticosteroids, gastro-intestinal bypass)
Use of anti-oxidants (vitamin E or C) or anti-TNF agents (pentoxifylline)
Poor glycaemic control diabetic (HbA1c>8.0%)
Decompensated cirrhosis INR(international normalized ratio)>1.3, albumin <35mg/dl or bilirubin >20 mmol/l or ascites or hepatic encephalopathy
Bleeding tendency precluding a repeat liver biopsy
Malignancy( excluding basal cell or squamous cell skin cancers)

Study & Design

• Study Type: Interventional
• Study Design: Not specified