Study of the Effects of Muscular Activity on Iron Metabolism - Full Text View

Sponsored by:	Rennes University Hospital
Information provided by:	Rennes University Hospital
ClinicalTrials.gov Identifier:	NCT00378469

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

MedlinePlus related topics: Exercise and Physical Fitness Urine and Urination

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Study of the Effects of Muscular Activity on Iron Metabolism: A Pilot Study on Healthy Volunteers

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:

45 minutes of exercise on the ergocycle; and
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

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

Keywords provided by Rennes University Hospital:

Hepcidin
Hemojuvelin
Iron
Healthy volunteers

Study placed in the following topic categories:

Metabolic Diseases
Hematologic Diseases
Anemia
Healthy
Iron Metabolism Disorders

Iron Overload
Iron
Metabolic Disorder
Anemia, Iron-Deficiency

Additional relevant MeSH terms:

Metabolic Diseases
Hematologic Diseases
Anemia
Anemia, Hypochromic

Iron Metabolism Disorders
Iron Overload
Anemia, Iron-Deficiency

ClinicalTrials.gov processed this record on May 07, 2009