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
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|ClinicalTrials.gov Identifier: NCT00658164|
Recruitment Status : Unknown
Verified July 2007 by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
Recruitment status was: Recruiting
First Posted : April 14, 2008
Last Update Posted : April 14, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Nonalcoholic Fatty Liver Disease||Other: Iron depletion treatment||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||October 2007|
|Estimated Primary Completion Date :||March 2009|
U.S. FDA Resources
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658164
|Contact: Silvia Fargion, firstname.lastname@example.org|
|U.O. Medicina Interna 1/B||Recruiting|
|Milan, Italy, 20122|
|Contact: Silvia Fargion, Prof. 39-02-5503-3301 email@example.com|
|Principal Investigator: Silvia Fargion, Prof.|
|Sub-Investigator: Luca Valenti, Md|