Evaluation of Body Iron Stores in Overweight Healthy Volunteers

Healthy Volunteers Clinical Trial

— FERNORM  

Official title:

Evaluation of Body Iron Stores in Overweight Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02304874
• Other study ID #: LOC/11-03
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: August 2014

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers
• Overweight

Intervention

Other:
• Phlebotomy

Locations

Country	Name	City	State
France	CHU Pontchaillou	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (1)

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. e — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of mobilized iron (AMI) in grams collected by phlebotomies to have a ferritin level < 50 µg/L	Phlebotomies will be performed every 14 days at the Clinical Investigation Unit, until ferritin level is below 50 µg/mL and/or hemoglobin is below 12 g/dL.	Every 14 days, up to 3 months
Secondary	Serum hepcidin level variation during the phlebotomy		Every 14 days, up to 3 months
Secondary	Serum soluble transferrin receptor variation during the phlebotomy		Every 14 days, up to 3 months