Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-30 @ 7:47 AM
Study NCT ID:
NCT00378469
Status:
UNKNOWN
Last Update Posted:
2007-07-12
First Post:
2006-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Effects of Muscular Activity on Iron Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019190', 'term': 'Iron Overload'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'lastUpdateSubmitDate': '2007-07-11', 'studyFirstSubmitDate': '2006-09-19', 'studyFirstSubmitQcDate': '2006-09-19', 'lastUpdatePostDateStruct': {'date': '2007-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics of urinary hepcidin'}, {'measure': 'Pharmacokinetics of blood hemojuvelin'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics of urine and blood iron, transferrin, interleukin-6 (IL-6) and ferritin'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepcidin', 'Hemojuvelin', 'Iron', 'Healthy volunteers'], 'conditions': ['Iron Overload', 'Iron Deficiency']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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:\n\n1. 45 minutes of exercise on the ergocycle; and\n2. no physical exercise.\n\nUrine and blood samples will be collected at both periods regularly to measure hemojuvelin, hepcidin, iron and transferrin levels.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male individuals aged between 18 and 40 years old\n* Body mass index (BMI) between 18 and 25\n* Normal at clinical examination\n* Normal biological variables\n* Written informed consent\n\nExclusion Criteria:\n\n* Mutation C282Y of the HFE gene\n* Iron metabolism abnormality\n* Inflammatory syndrome\n* Chronic pathology or ongoing treatment\n* Tobacco smoking, alcohol consuming more than 30g/day\n* History of transfusion or blood-giving within 3 months\n* Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV.'}, 'identificationModule': {'nctId': 'NCT00378469', 'briefTitle': 'Study of the Effects of Muscular Activity on Iron Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Study of the Effects of Muscular Activity on Iron Metabolism: A Pilot Study on Healthy Volunteers', 'orgStudyIdInfo': {'id': 'DGS 2006/0415'}, 'secondaryIdInfos': [{'id': 'LOC/05-07'}, {'id': 'CIC0203/061'}]}, 'armsInterventionsModule': {'interventions': [{'name': '45 minute exercise on ergocycle', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35033', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre Brissot, MD', 'role': 'CONTACT', 'email': 'pierre.brissot@univ-rennes1.fr', 'phone': '33-2-9928-4297'}, {'name': 'Pierre Brissot, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yves Deugnier, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fabrice Lainé, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service des Maladies du Foie - Hôpital de Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '35033', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre Rochcongar, MD', 'role': 'CONTACT', 'email': 'pierre.rochcongar@chu-rennes.fr', 'phone': '33-2-9928-9323'}, {'name': 'Pierre Rochcongar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jocelyne Beillot, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Unité de Biologie et Médecine du Sport - Hôpital de Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'centralContacts': [{'name': 'Pierre Brissot, MD', 'role': 'CONTACT', 'email': 'pierre.brissot@univ-rennes1.fr', 'phone': '33-2-9928-4297'}, {'name': 'Fabrice Lainé, MD', 'role': 'CONTACT', 'email': 'fabrice.laine@chu-rennes.fr', 'phone': '33-2-9928-3715'}], 'overallOfficials': [{'name': 'Pierre Brissot, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rennes University Hospital'}, {'name': 'Bruno Laviolle, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Rennes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}}}}