NCT02304874

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

1.9 years

First QC Date

November 24, 2014

Last Update Submit

May 22, 2023

Conditions

Healthy VolunteersOverweight

Keywords

FerritinsIron OverloadMetabolic SyndromeVenesection therapyVolunteers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (1)

Phlebotomy

OTHER

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

Interventions

PhlebotomyOTHER
Phlebotomy

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Pontchaillou

Rennes, 35000, France

Location

Related 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. eCollection 2015.

    PMID: 26030828RESULT

MeSH Terms

Conditions

OverweightIron OverloadMetabolic Syndrome

Interventions

Phlebotomy

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsIron Metabolism DisordersMetabolic DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

Blood Specimen CollectionSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Bruno Laviolle, MD, PhD

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

    STUDY CHAIR

  • Caroline Jezequel, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2014

First Posted

December 2, 2014

Study Start

July 1, 2011

Primary Completion

June 1, 2013

Study Completion

August 1, 2014

Last Updated

May 24, 2023

Record last verified: 2023-05

Locations

FR(1)