Effect of Iron Depletion by Phlebotomy Plus Lifestyle Changes vs. Lifestyle Changes Alone on Liver Damage in Patients With Nonalcoholic Fatty Liver Disease With Increased Iron Stores

Exclusion Criteria

• •Pregnant or lactating female
• •Diagnosis of or a history of:
• •Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing's syndrome or acromegaly
• •Acute metabolic complication such as ketoacidosis or hyperosmolar state within the past 6 months
• •Alcohol consumption \> 20 g/day for females and \> 30 g/day for males
• •BMI ≥ 35 Kg/ m2
• •Other liver disease such as viral hepatitis, autoimmune hepatitis, Wilson disease, as defined by ceruloplasmin below normal limits and liver histology consistent with Wilson disease. Alpha-1-antitrypsin deficiency as defined by alpha-1-antitrypsin level less than 80 mg/dl or PiZ/PiZ or PiZ/PiS genotype. \*Hemochromatosis, as defined by homozygosity for the C282Y HFE mutation or compound heterozygosity for C282Y/H63D mutations or Hepatic Iron Index ≥ 1.9.
• •Advanced liver disease (Child B/C cirrhosis), portal hypertension, hepatocellular carcinoma.
• •Congestive heart failure (NYHA I-IV) and unstable ischemic heart disease, systolic dysfunction (ejection fraction \< 45%)
• •Any of the following ECG abnormalities: II or III degree Atrial Ventricular \*Block, QT\>500msec, repolarization defect suggestive of ischemia
• •Malignancy within the last 5 years
• •Serum creatinine levels \> 1.5 mg/dl males, \> 1.4 mg/dl females
• •TSH outside of normal range
• •Use of drugs known to induce NAFLD: corticosteroids, methotrexate, zidovudine, amiodarone, GH, estrogens, tamoxifene, tetracycline
• •Lipodystrophy, dysbetalipoproteinemia, inflammatory bowel disease, HIV infection
• •Basal hemoglobin levels \< 11 g/dl