Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-29 @ 7:22 PM
Study NCT ID:
NCT01344928
Status:
UNKNOWN
Last Update Posted:
2011-04-29
First Post:
2011-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Short-time High-intensity Interval Training on Tissue Glucose and Fat Metabolism in Healthy Subjects and Patients With Type 2 Diabetes
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'lastUpdateSubmitDate': '2011-04-28', 'studyFirstSubmitDate': '2011-04-28', 'studyFirstSubmitQcDate': '2011-04-28', 'lastUpdatePostDateStruct': {'date': '2011-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-29', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus', 'Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '32785654', 'type': 'DERIVED', 'citation': 'Ojala R, Motiani KK, Ivaska KK, Arponen M, Eskelinen JJ, Virtanen KA, Loyttyniemi E, Heiskanen MA, U-Din M, Nuutila P, Kalliokoski KK, Hannukainen JC. Bone Marrow Metabolism Is Impaired in Insulin Resistance and Improves After Exercise Training. J Clin Endocrinol Metab. 2020 Dec 1;105(12):e4290-303. doi: 10.1210/clinem/dgaa516.'}, {'pmid': '31425383', 'type': 'DERIVED', 'citation': 'Motiani KK, Collado MC, Eskelinen JJ, Virtanen KA, Loyttyniemi E, Salminen S, Nuutila P, Kalliokoski KK, Hannukainen JC. Exercise Training Modulates Gut Microbiota Profile and Improves Endotoxemia. Med Sci Sports Exerc. 2020 Jan;52(1):94-104. doi: 10.1249/MSS.0000000000002112.'}, {'pmid': '29717337', 'type': 'DERIVED', 'citation': 'Heiskanen MA, Motiani KK, Mari A, Saunavaara V, Eskelinen JJ, Virtanen KA, Koivumaki M, Loyttyniemi E, Nuutila P, Kalliokoski KK, Hannukainen JC. Exercise training decreases pancreatic fat content and improves beta cell function regardless of baseline glucose tolerance: a randomised controlled trial. Diabetologia. 2018 Aug;61(8):1817-1828. doi: 10.1007/s00125-018-4627-x. Epub 2018 May 2.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to investigate the effects of short-time high-intensity interval training on tissue glucose and fat metabolism in healthy lean subjects and type 2 diabetic patients using modern and noninvasive imaging methods positron emission tomography (PET), magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe healthy patients\n\n1. Age 40-55\n2. BMI 18.5-30\n3. Fasting plasma glucose less than 6.1 mmol/l\n4. Normal glucose tolerance test (OGTT)\n\nThe type 2 diabetic patients:\n\n1. Age-, sex-, and BMI-matched with the study subjects in the phase 1\n2. In a good treatment balance\n3. Glycated haemoglobin (HbA1c) less than 7.5 mmol/l\n4. Two hours glucose value in oral glucose tolerance test (OGTT) less than 10.0 mmol/l\n\nExclusion Criteria:\n\nThe healthy patients\n\n1. Blood pressure \\> 140/90 mmHg\n2. Any chronic disease\n3. Any chronic medical defect or injury which hinder/interfere everyday life\n4. History of anorexia nervosa or bulimia\n5. History of rest or exercise-induced asthma\n6. Previous use of anabolic steroids, additives or any other substrates\n7. Smoking of tobacco, taking of snuffs, or use of narcotics.\n8. Significant use of alcohol\n9. Any other condition that in the opinion of the investigator could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results\n10. Presence of any ferromagnetic objects that would make MR imaging contraindicated\n11. Current or history of regular and systematic exercise training\n12. VO2max \\>40 ml/min/kg\n\nThe type 2 diabetic patients:\n\n1. Any other chronic disease than diabetes\n2. Blood pressure \\> 140/90 mmHg\n3. Any chronic medical defect or injury which hinder/interfere everyday life\n4. History of anorexia nervosa or bulimia\n5. History of rest or exercise-induced asthma\n6. Smoking of tobacco, taking of snuffs, or use of narcotics.\n7. Any other condition that in the opinion of the investigator could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results\n8. Presence of any ferromagnetic objects that would make MRI imaging contraindicated\n9. Current or history of regular and systematic exercise training\n10. VO2max \\>40 ml/ min/kg'}, 'identificationModule': {'nctId': 'NCT01344928', 'acronym': 'HITPET', 'briefTitle': 'The Effects of Short-time High-intensity Interval Training on Tissue Glucose and Fat Metabolism in Healthy Subjects and Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'orgStudyIdInfo': {'id': '95/180/2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIT training', 'interventionNames': ['Behavioral: HIT exercise intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aerobic exercise training', 'interventionNames': ['Behavioral: Aerobic exercise intervention']}], 'interventions': [{'name': 'HIT exercise intervention', 'type': 'BEHAVIORAL', 'armGroupLabels': ['HIT training']}, {'name': 'Aerobic exercise intervention', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Aerobic exercise training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20521', 'city': 'Turku', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Jarna C Hannukainen, PhD', 'role': 'CONTACT', 'email': 'jarna.hannukainen@tyks.fi', 'phone': '+358-2-3131878'}, {'name': 'Jarna C Hannukainen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kari K Kalliokoski, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Joonas J Eskelinen, BM', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anna Savolainen, BM', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ilkka Heinonen, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kirsi A Virtanen, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jukka Kemppainen, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Juhani Knuuti, Professor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pirjo Nuutila, Professor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jussi Pärkkä, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Virva Lepomäki, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Riitta Parkkola, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Turku PET Centre', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'European Foundation for the Study of Diabetes', 'class': 'OTHER'}, {'name': 'Ministry of Education and Culture, Finland', 'class': 'OTHER'}, {'name': 'Orion Farmos Research Foundation', 'class': 'UNKNOWN'}, {'name': 'Academy of Finland', 'class': 'OTHER'}, {'name': 'Turku PET Centre', 'class': 'UNKNOWN'}, {'name': 'University of Turku', 'class': 'OTHER'}, {'name': 'Verve Research, Oulu, Finland', 'class': 'OTHER'}, {'name': 'University of Helsinki', 'class': 'OTHER'}], 'responsibleParty': {'oldOrganization': 'Jarna Hannukainen, Turku PET Centre'}}}}