Study of the Effects of Muscular Activity on Iron Metabolism

July 11, 2007 updated by: Rennes University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Rennes, France, 35033
        • Recruiting
        • Service des Maladies du Foie - Hôpital de Pontchaillou
        • Sub-Investigator:
          • Fabrice LAINE, MD
        • Contact:
        • Principal Investigator:
          • Pierre Brissot, MD
        • Sub-Investigator:
          • Yves Deugnier, MD
      • Rennes, France, 35033
        • Recruiting
        • Unité de Biologie et Médecine du Sport - Hôpital de Pontchaillou
        • Contact:
        • Principal Investigator:
          • Pierre Rochcongar, MD
        • Sub-Investigator:
          • Jocelyne Beillot, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pharmacokinetics of urinary hepcidin
Pharmacokinetics of blood hemojuvelin

Secondary Outcome Measures

Outcome Measure
Pharmacokinetics of urine and blood iron, transferrin, interleukin-6 (IL-6) and ferritin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Study Chair: Bruno Laviolle, MD, Rennes University Hospital
  • Principal Investigator: Pierre Brissot, MD, Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Study Registration Dates

First Submitted

September 19, 2006

First Submitted That Met QC Criteria

September 19, 2006

First Posted (Estimate)

September 20, 2006

Study Record Updates

Last Update Posted (Estimate)

July 12, 2007

Last Update Submitted That Met QC Criteria

July 11, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DGS 2006/0415
  • LOC/05-07
  • CIC0203/061

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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