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
Recruitment status was: Recruiting
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.
|Nonalcoholic Fatty Liver Disease||Other: Iron depletion treatment||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
- To determine in a 24 month controlled study whether iron depletion by phlebotomy improves insulin sensitivity, and thereby reduces hepatic steatosis and inflammation in subjects with nonalcoholic steatohepatitis [ Time Frame: 24 months ]
- To assess the effect of iron depletion on glucose tolerance status. Glucose tolerance will be determined by OGTT in subjects without type 2 diabetes (T2D), and by HbA1c levels and the change in dosage of pharmacological therapy in those with T2D. [ Time Frame: 24 months ]
|Study Start Date:||October 2007|
|Estimated Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Other: Iron depletion treatment
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00658164
|Contact: Silvia Fargion, email@example.com|
|U.O. Medicina Interna 1/B||Recruiting|
|Milan, Italy, 20122|
|Contact: Silvia Fargion, Prof. 39-02-5503-3301 firstname.lastname@example.org|
|Principal Investigator: Silvia Fargion, Prof.|
|Sub-Investigator: Luca Valenti, Md|