Insulin resistance-associated hepatic iron overload (IR-HIO), also defined as dysmetabolic iron overload syndrome or dysmetabolic liversiderosis, is a common cause or iron overload in France, mainly in middle-age patients with increased serum ferritin levels associated with normal serum transferrin saturation, and normal serum iron concentration in the absence of other known cause of increased serum ferritin levels. Treatment includes a combination of dietary measures and physical activity to correct metabolic disorders. Phlebotomies seem to be beneficial when serum ferritin level is high. This study aims at comparing the effect of iron depletion (by phlebotomy) plus lifestyle and diet advices versus lifestyle and diet advices alone on blood glucose level and insulin sensitivity in subjects with IR-HIO in order to assess the benefits of phlebotomies on the reduction of risk of diabetes and cardiovascular associated complications.
Non applicable
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
274
From 300 to 400mL for women; From 350 to 450mL for men
2 Booklets with Dietary and physical activity advices
Clermont-Ferrand University Hospital
Clermont-Ferrand, France
La Roche Sur Yon Hospital
La Roche-sur-Yon, France
Lorient Hospital
Lorient, France
Service des maladies du foie - Hôpital Pontchaillou
Rennes, France
Saint-Malo Hospital
St-Malo, France
Fasting blood glycemia (T0 of Oral Glucose Tolerance Test)
Time frame: 12 months
Rate of Body mass index > 25 kg/m²
Time frame: 12 months
Rate of systolic blood pressure ≥ 130mmHg or diastolic blood pressure ≥ 85 mmHg or antihypertensive treatment
Time frame: 12 months
Rate of abdominal obesity (waist measurement ≥ 94 cm for men and ≥ 80 cm for women)
Time frame: 12 months
Rate of fasting triglyceridemia ≥ 1.7 mmol/L or triglyceride-lowering treatment
Time frame: 12 months
Rate of fasting HDL cholesterol < 1.03 mmol/L for men and < 1.29 mmol/L for women or HDL cholesterol-elevating treatment
Time frame: 12 months
Rate of fasting glycemia ≥ 5.6 mmol/L
Time frame: 12 months
HbA1c value
Time frame: 12 months
Quality of life estimated with SF36 form and tolerance to treatment
Time frame: 12 months
Insulinoresistance indexes calculated at T0 and T30 min of Oral Glucose Tolerance Test (OGTT)
Time frame: 12 months
Biological markers: CRP, hyaluronic acid, fibrometer
Time frame: 12 months
myocardial deformation
Two dimensional (2D) speckle tracking echocardiography (STE)
Time frame: 12 months
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