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Study of the Effects of Muscular Activity on Iron Metabolism

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Rennes University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00378469
First received: September 19, 2006
Last updated: July 11, 2007
Last verified: May 2007
History of Changes
  Purpose

The aim of this study is to evaluate the effect of muscular exercise on iron metabolism in healthy volunteers. Fourteen healthy male subjects will have to pedal on an ergocycle for 45 minutes, and urine and blood samples will be collected regularly to measure hemojuvelin, hepcidin, iron and transferrin levels.


Condition Intervention
Iron Overload
Iron Deficiency
 Behavioral: 45 minute exercise on ergocycle

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Study of the Effects of Muscular Activity on Iron Metabolism: A Pilot Study on Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Pharmacokinetics of urinary hepcidin
  • Pharmacokinetics of blood hemojuvelin

Secondary Outcome Measures:
  • Pharmacokinetics of urine and blood iron, transferrin, interleukin-6 (IL-6) and ferritin

Estimated Enrollment: 14
Study Start Date: September 2006
Detailed Description:

Hemojuvelin has been described as interfering with hepcidin, a key regulator of iron homeostasis. Hemojuvelin is mainly produced by muscle, and the relationship between exercise and iron metabolism can be questioned about.

The aim of this study is to evaluate the effect of muscular exercise on iron metabolism in healthy volunteers. Fourteen healthy male subjects will be investigated at two periods according to a cross-over design after:

  1. 45 minutes of exercise on the ergocycle; and
  2. no physical exercise.

Urine and blood samples will be collected at both periods regularly to measure hemojuvelin, hepcidin, iron and transferrin levels.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male individuals aged between 18 and 40 years old
  • Body mass index (BMI) between 18 and 25
  • Normal at clinical examination
  • Normal biological variables
  • Written informed consent

Exclusion Criteria:

  • Mutation C282Y of the HFE gene
  • Iron metabolism abnormality
  • Inflammatory syndrome
  • Chronic pathology or ongoing treatment
  • Tobacco smoking, alcohol consuming more than 30g/day
  • History of transfusion or blood-giving within 3 months
  • Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00378469

Contacts
Contact: Pierre Brissot, MD 33-2-9928-4297 pierre.brissot@univ-rennes1.fr
Contact: Fabrice Lainé, MD 33-2-9928-3715 fabrice.laine@chu-rennes.fr

Locations
France
Service des Maladies du Foie - Hôpital de Pontchaillou Recruiting
Rennes, France, 35033
Contact: Pierre Brissot, MD     33-2-9928-4297     pierre.brissot@univ-rennes1.fr    
Principal Investigator: Pierre Brissot, MD            
Sub-Investigator: Yves Deugnier, MD            
Sub-Investigator: Fabrice Lainé, MD            
Unité de Biologie et Médecine du Sport - Hôpital de Pontchaillou Recruiting
Rennes, France, 35033
Contact: Pierre Rochcongar, MD     33-2-9928-9323     pierre.rochcongar@chu-rennes.fr    
Principal Investigator: Pierre Rochcongar, MD            
Sub-Investigator: Jocelyne Beillot, MD            
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Pierre Brissot, MD Rennes University Hospital
Study Chair: Bruno Laviolle, MD Rennes University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00378469     History of Changes
Other Study ID Numbers: DGS 2006/0415, LOC/05-07, CIC0203/061
Study First Received: September 19, 2006
Last Updated: July 11, 2007
Health Authority: France: DGS - Direction Générale de la Santé

Keywords provided by Rennes University Hospital:
Hepcidin
Hemojuvelin
Iron
Healthy volunteers

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Iron Overload
Anemia, Hypochromic
Anemia
 Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013