The purpose of this study is to evaluate efficacy of phlebotomy on insulin sensitivity as evaluated by euglycemic-hyperinsulinic clamp in insulin resistance-associated hepatic iron overload patients.
The main objective of this study is to evaluate in patients with HSD effects of treatment with phlebotomy rules with lifestyle and dietary rules versus lifestyle modifications alone on peripheral insulin resistance (assessed by hyperinsulinemic clamp). Secondary objectives are: * to study in all patients with HSD the relationship between the amount of iron intrahepatic and degree of peripheral insulin resistance and liver before therapeutic intervention. * to study and compare the effects of phlebotomy treatment versus no treatment on: * Plasma levels of adipocytokines, * Plasma concentrations of inflammatory markers and markers of insulin resistance, * The serum ferritin, * The post-hepatic clearance of insulin, * The surface of the abdominal visceral fat and subcutaneous abdominal.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
13
7 ml/kg without exceeding 500 mL
dietary and lifestyle counseling
CHU
Nantes, France
CHU
Rennes, France
Glucose Infusion Rate by euglycemic-hyperinsulinic clamp
Time frame: 6 months
hepatic parameters
Time frame: 6 months
inflammation markers
IL-6, TNF alpha, CRP
Time frame: 6 months
Adipokins markers
adiponectin, PAI1, leptin
Time frame: 6 months
SHBG
Time frame: 6 months
HOMA-IR
Time frame: 6 months
Hepatic iron overload (MRI)
transaminase (ALT, AST), gamma GT
Time frame: 6 months
Abdominal and sub-cutaneous fat surface (MRI)
Time frame: 6 months
iron parameters
serum iron, ferritin, saturation of transferrin
Time frame: at 6 months
lipid profile
HDL-c, LDL-c, triglycerides
Time frame: at 6 months
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