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

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.

Study Overview

• Status: Completed
• Conditions: Overweight; Healthy Volunteers
• Intervention / Treatment: Other: 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).

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35000
    • CHU Pontchaillou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Phlebotomy; 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.	Other: Phlebotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Serum hepcidin level variation during the phlebotomy	Every 14 days, up to 3 months
Serum soluble transferrin receptor variation during the phlebotomy	Every 14 days, up to 3 months

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Study Chair: Bruno Laviolle, MD, PhD, Centre d'Investigation Clinique Inserm 1414, Service de Pharmacologie Clinique, Hôpital de Pontchaillou; Principal Investigator: Caroline Jezequel, MD, Centre d'Investigation Clinique Inserm 1414, Service de Pharmacologie Clinique, Hôpital de Pontchaillou

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: November 24, 2014
• First Submitted That Met QC Criteria: November 27, 2014
• First Posted (Estimate): December 2, 2014

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Metabolic Syndrome; Volunteers; Iron Overload; Ferritins; Venesection therapy
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: LOC/11-03