Study of the Effects of Muscular Activity on Iron Metabolism

Sponsor

Rennes University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00378469

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Iron Overload Iron Deficiency	Behavioral: 45 minute exercise on ergocycle	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

14 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Official Title:

Study of the Effects of Muscular Activity on Iron Metabolism: A Pilot Study on Healthy Volunteers

Study Start Date :

Sep 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Service des Maladies du Foie - Hôpital de Pontchaillou	Rennes		France	35033
2	Unité de Biologie et Médecine du Sport - Hôpital de Pontchaillou	Rennes		France	35033