Evaluation of Body Iron Stores in Overweight Healthy Volunteers (FERNORM)

Rennes University Hospital

Status: Completed

Conditions: Overweight; Healthy Volunteers

Treatments: Other: Phlebotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02304874

LOC/11-03

Details and patient eligibility

About

Normal body iron store value in overweight subjects is currently not described in literature. The comparison of this value with body iron levels in patients suffering from dysmetabolic iron overload syndrome (DIOS) could allow to quantify iron overload in this condition. The purpose of the study is to determine iron levels in healthy overweight volunteers, and to compare them to DIOS patients treated with phlebotomy.

Full description

Normal body iron store value in overweight subjects is currently not described in literature. The comparison of this value with body iron levels in patients suffering from dysmetabolic iron overload syndrome (DIOS) could allow to quantify iron overload in this condition.

DIOS is the leading cause of hyperferritinemia and mainly affects men between 45 and 60 years. It is characterized by unexplained hyperferritinemia associated to metabolic disorders (including overweight) and iron overload, objectified by MRI or liver biopsy.

Some authors suggest that hyperferritinemia associated to metabolic disorders is the expression of an inflammatory syndrome caused by insulin resistance and steatohepatitis, and not the manifestation of real iron overload.

The debate surrounding iron overload in DIOS is related to the limits of the current analysis methods (phlebotomy, liver iron concentration, MRI). At present, phlebotomy is the standard method used to determine body iron stores.

Using this method, the purpose of the study is to determine iron levels in healthy overweight volunteers, and to compare them to DIOS patients treated with phlebotomy included in another ongoing clinical trial (SAIGNEES - ClinicalTrials.gov Identifier: NCT01045525).

Enrollment: 14 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male,
• At least 18 years old
• BMI > 25 Kg/m2
• Serum ferritin level between 100 et 300 µg/L
• Written informed consent

Exclusion criteria

• Blood donations in the past two years
• Alcohol consumption more than 30 g/day
• Inflammatory syndrome (CRP > 10 mg/L)
• Inflammatory, dysimmunitary or cancerous disease
• Hepatic cytolysis
• Transferrin saturation > 45%
• Person involved in another clinical trial
• Person with a measure of legal protection (guardianship)
• Person who reached the annual limit for compensation provided by biomedical research
• Hemoglobin < 13 g/dL
• Uncontrolled heart failure or coronary insufficiency
• Abnormal ECG
• Echocardiographic abnormalities contraindicating phlebotomy
• Hepatic, renal or respiratory insufficiency
• Superficial venous network insufficiency

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Phlebotomy

Other group

Description:

Phlebotomies will be performed every 14 days at the Clinical Investigation Unit (CIU) until the value of ferritin level is below 50 µg/mL and/or the value of hemoglobin level is below 12 g/dL.

Treatment:

Other: Phlebotomy