Nonalcoholic Fatty Liver Disease Clinical Trial
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
baseline hemoglobin values and venesection tolerance, until ferritin < 30 ng/ml and
transferrin saturation < 25%. Weekly phlebotomies will be allowed for carriers of the C282Y
HFE mutation. Smaller phlebotomies (250 cc) will be allowed for carriers of
beta-thalassaemia trait. Maintenance phlebotomies (as much as required) will then be
instituted to keep iron stores depleted (ferritin < 50 ng/ml and transferrin saturation <
25%, MCV <85 fl). Before starting treatment, patients will undergo ECG, and in the presence
of hyperglycemia or hypertension also echocardiography (see exclusion criteria).
Change in diabetes medication dosage or start of new therapy will be allowed for HbA1C
values <6% or ≥ 7%. According to accepted criteria, previously untreated patients should be
treated with metformin. If possible, newly diagnosed hypertension should be treated with
Ace-inhibitors.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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