Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01572818
Study Brief:
Protocol Section:
NCT01572818