Evaluation of Body Iron Stores in Overweight Healthy Volunteers

NCT ID: NCT02304874

Last Updated: 2023-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2014-08-31

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).

Conditions

Healthy Volunteers; Overweight

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Phlebotomy

Intervention Type: OTHER

Interventions

Phlebotomy

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruno Laviolle, MD, PhD

Role: STUDY_CHAIR

Centre d'Investigation Clinique Inserm 1414, Service de Pharmacologie Clinique, Hôpital de Pontchaillou

Caroline Jezequel, MD

Role: PRINCIPAL_INVESTIGATOR

Centre d'Investigation Clinique Inserm 1414, Service de Pharmacologie Clinique, Hôpital de Pontchaillou

Locations

CHU Pontchaillou

Rennes, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 26030828 (View on PubMed)

Other Identifiers

LOC/11-03

Identifier Type: -

Identifier Source: org_study_id