Clinical trial: Phlebotomy and Lifestyle and Diet Advices vs Lifestyle and Diet Advices Only in Patients With Dysmetabolic Liversiderosis (NCT01045525)

Eligibility criteria:
Inclusion Criteria:

          -  Age over 18

          -  Signed written informed consent

          -  Ferritin ≥ 450 µg/L and ≤ 1500 µg/L

          -  Hepatic iron overload proved by MRI or histological biochemical measurement (Iron
             hepatic concentration ≥ 50 μmol/g)

          -  At least one of the following criteria :

               -  Body mass index > 25 kg/m²

               -  Systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90 mmHg or
                  antihypertensive treatment

               -  Abdominal obesity (waist measurement ≥ 94 cm for men and ≥ 80 cm for women)

               -  Fasting triglyceridemia ≥ 1.7 mmol/L or triglyceride-lowering treatment

               -  Fasting HDL cholesterol < 1.03 mmol/L for men and < 1.29 mmol/L for women or HDL
                  cholesterol-elevating treatment

               -  Fasting blood glycemia ≥ 5.6 mmol/L

        Exclusion Criteria:

          -  Subjects deprived of their liberty by judicial or administrative decision

          -  Pregnant women

          -  Other causes of increased serum ferritin levels:

               -  Inflammatory syndrome (CRP >10 mg/L) or inflammatory, immune or malignant
                  diseases

               -  Hyper-hemolysis

               -  Alcohol consumption more than 210 g for men and 140 g for women per week within
                  the year before inclusion

               -  Haemochromatosis established by the C282Y homozygous genotype

               -  Chronic hepatic cytolysis due to : viral infection (HBV, HCV), alcohol,
                  hyperthyroid disease, celiac disease, drug or immune hepatitis

               -  Increased serum ferritin levels - cataract syndrome (familial cataract or
                  personal history of cataract before 50 years of age)

               -  Low ceruloplasmin level

               -  Porphyria (cutaneous signs)

          -  Contraindication of phlebotomy

               -  Haemoglobin <13 g/dL for men and <12g/dL for women (threshold established by the
                  French Blood Agency)

               -  Congestive heart failure or coronary heart disease

               -  Hepatic failure (TP<60%), renal failure (GFR <50mL/min) or respiratory
                  insufficiency (chronic dyspnea)

               -  Poor venous system

          -  Fasting blood glycemia > 7 mmol/L or type 1 or type 2 diabetes, treated or not

          -  Use of drugs known to have anti-steatotic effects : metformin, thiazolidinedione
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug.  Blood pressure is 120/80 mm Hg and pulse is 70/min.  Oxygen saturation is 99% on room air.  BMI is 24 kg/m2.  Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis.

Patient description (patient's own words): I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550  μg/L. The doctor diagnosed me with iron overload.

Does the patient match the trial criteria? Contradiction