Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-02-25 @ 11:01 PM
Study NCT ID:
NCT02001805
Status:
UNKNOWN
Last Update Posted:
2013-12-05
First Post:
2011-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Marathon Runners Compared to Sedentary Matched Control Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood, plasma, muscle tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-11-28', 'studyFirstSubmitDate': '2011-05-18', 'studyFirstSubmitQcDate': '2013-11-28', 'lastUpdatePostDateStruct': {'date': '2013-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fitness', 'timeFrame': 'one day', 'description': 'Lactate threshold VO2max Running economy Lactate Peak'}, {'measure': 'Cognitive Function', 'timeFrame': 'one day', 'description': 'Memory, concentration, personality, intelligence'}, {'measure': 'Blood', 'timeFrame': 'one day', 'description': '3 hour Oral Glucose Tolerance test (glucose, insulin, c-peptide) Fasting blood measurements ( lever, kidney, immune system, colesterol parameters) DNA'}, {'measure': 'Muscle biopsy', 'timeFrame': 'one day', 'description': 'Gene transcription Methylation'}, {'measure': 'Body Composition', 'timeFrame': 'one day', 'description': 'DXA scanning: Fat%, muscle mass, lean body mass, BMD MR scanning: Amount of visceral fat, volume of thighs'}], 'secondaryOutcomes': [{'measure': 'Activity level and diet', 'timeFrame': '7 days', 'description': 'Subjects are carrying a step pedometer for 7 days They are registrering their diet for 4 days They are answering questionaires about daily activity level and health now and in the past'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The investigators wish to compare very active runners in healthy untrained control subjects on a number of parameters.\n\nThe project aims to understand the underlying mechanisms by which physical inactivity causes diseases. This the investigators will study the full spectrum of physical activity, from the most inert of the most active people. The investigators have already collected muscle biopsies and established stem cells from people with Type 2 diabetes, obese healthy and normal weight healthy. In this study, the investigators will establish a cohort of highly physically active marathon runners. In a case-control design, the investigators compare muscle stem cell function across the entire spectrum of physical activity / inactivity.', 'detailedDescription': "There has never been as much focus on running as in these days. With the knowledge the investigators have today, there is reason to believe that it is healthy to run both in a physical sense, but perhaps also in terms of brain function. However, there has not previously carried out extensive comparative studies of very active runners and healthy untrained control subjects. In this project the investigators will characterize the degree of training in subjects as the investigators will carry out various forms of physiological studies on the subjects' fitness level. The investigators will examine whether there is a linkage between training level and brain function.\n\nThe investigators will also examine muscle function at the molecular level. The investigators will isolate stem cells (satellite cells) from muscles biopsy and establish primary muscle cell cultures. By electrical stimulation of these cells in vitro, the investigators can emulate a muscle contraction as during physical activity. The investigators will test the overall hypothesis that physical activity affects stem cell function.\n\nThe investigators will further study whether epigenetic phenomena (methylation) of selected DNA sequences are sensitive to training level."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Runners with high amount of training', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 10 marathons, 2 within the last year or 50 km/week the last 5 years\n\nExclusion Criteria:\n\n* smokers, any medication, chronic diseases, digestion of performance enhancing drugs, pregnancy, alcohol abuse'}, 'identificationModule': {'nctId': 'NCT02001805', 'briefTitle': 'Marathon Runners Compared to Sedentary Matched Control Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Fitness, Glucosemetabolism, Cognitive Function, Bodycomposition and Muscular Function in Active Runners and Matched Controls', 'orgStudyIdInfo': {'id': 'Marathon Cohorte'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Marathon runners', 'description': 'Very active runners that have been running \\> 10 marathons, 2 within the last year, or an amount of 50 km/week for the last 5 years'}, {'label': 'Control subjects', 'description': 'Healthy normal weight control subjects, with a low activity level \\< 1 hour phsyical activity pr. week. They are matched with runners on age, BMI and gender'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Matthew Laye, Post Doc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Louise S Hansen, Cand Scient', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mille B Nielsen, Stud. Med', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Center of Inflammation and Metabolism, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Louise S Hansen, Cand. Scient', 'role': 'CONTACT', 'email': 'louise_seier_84@hotmail.com', 'phone': '35450746'}, {'name': 'Matthew Laye, Post doc', 'role': 'CONTACT', 'email': 'mjlaye@gmail.com'}], 'overallOfficials': [{'name': 'Bente K Pedersen, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Center of Inflammation and Metabolism'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inge Holm', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Augustinus Foundation, Denmark.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Section CIM', 'investigatorFullName': 'Inge Holm', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}