Clinical trial: Effects of Phlebotomy on Insulin Sensitivity in Insulin Resistance-associated Hepatic Iron Overload Patients (NCT01572818)

Eligibility criteria:
Inclusion Criteria:

          -  Age between 18 and 70 years

          -  Ferritin between 450 and 1000 µg/L

          -  Hepatic iron overload proved by MRI (CHF >36 µmol/g)

          -  Body mass index > 25 kg/m²

          -  Fasting glycemia <1,26 g/L

          -  HbA1c < 6,5%

          -  Signed written and informed consent

        Exclusion Criteria:

          -  Other causes of hyperferritinemia:

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

               -  Hyperferritinemia-cataract syndrome (familial cataract or personal history of
                  cataract before 50 years old)

               -  Low ceruloplasmin level

               -  Porphyria (cutaneous signs)

               -  Haemochromatosis established by the genotype (C282Y homozygous or C282Y/H63D
                  coumpound heterozygous genotypes)

          -  Contraindication of phlebotomy

               -  Haemoglobin <13,5 g/dL (threshold established by the Etablissement Français du
                  Sang)

               -  Heart failure or coronary heart diseases

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

               -  Poor venous system

          -  Viral, immune, genetic, vascular, malignant or toxic chronic hepatic disease

          -  Alcohol consumption more than 21 doses per week during 5 years or more

          -  Type 1 or type 2 diabetes

          -  Oral anti-diabetic, corticoids or immune suppressor drugs

          -  Hepatic severe disease

          -  Claustrophobia, having a pace-maker or intracerebral clips

          -  Subjects deprived of their liberty by judicial or administrative decision, subjects
             that are not affiliated to social security or topics exclusion period of a previous
             study
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.
Subject must be at most 70 Years

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? 0