Status:
UNKNOWN
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
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions:
Nonalcoholic Fatty Liver Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Patients will be randomized to lifestyle changes alone or lifestyle changes associated with iron depletion. Iron depletion will be achieved by removing 350 cc of blood every 10-15 days according to b...
Eligibility Criteria
Inclusion
- Age ≥ 18 \< 75 years
- Ferritin \> 250 ng/ml and/or stainable iron at biopsy
- NAS ≥ 2 and/or NAS 1 and stage≥1 at liver histology
- Willingness to maintain diet and exercise during the full course of the study
- Written informed consent to participate to the study and to have the specific genetic tests performed
- Ability to comply with all study requirements
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00658164
Start Date
October 1 2007
Last Update
April 14 2008
Active Locations (1)
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1
U.O. Medicina Interna 1/B
Milan, Italy, 20122