Clinical trial NCT02304874: Evaluation of Body Iron Stores in Overweight Healthy Volunteers
Official title: Evaluation of Body Iron Stores in Overweight Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Overweight
Keywords: Ferritins
Iron Overload
Metabolic Syndrome
Venesection therapy
Volunteers
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Amount of mobilized iron (AMI) in grams collected by phlebotomies to have a ferritin level < 50 µg/L
timeFrame: Every 14 days, up to 3 months
Secondary outcomes:
measure: Serum hepcidin level variation during the phlebotomy
timeFrame: Every 14 days, up to 3 months
measure: Serum soluble transferrin receptor variation during the phlebotomy
timeFrame: Every 14 days, up to 3 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Pontchaillou
Study officials:
affiliation: Centre d'Investigation Clinique Inserm 1414, Service de Pharmacologie Clinique, Hôpital de Pontchaillou
name: Bruno Laviolle, MD, PhD
role: STUDY_CHAIR
affiliation: Centre d'Investigation Clinique Inserm 1414, Service de Pharmacologie Clinique, Hôpital de Pontchaillou
name: Caroline Jezequel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jezequel C, Laine F, Laviolle B, Kiani A, Bardou-Jacquet E, Deugnier Y. Both hepatic and body iron stores are increased in dysmetabolic iron overload syndrome. A case-control study. PLoS One. 2015 Jun 1;10(6):e0128530. doi: 10.1371/journal.pone.0128530. eCollection 2015.