Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-03-08 @ 4:27 AM
Study NCT ID:
NCT01698502
Status:
COMPLETED
Last Update Posted:
2014-04-24
First Post:
2012-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Physical Training and the Incretin Effect
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michaeltl@sund.ku.dk', 'phone': '+45 3532 7519', 'title': 'Michael Lund', 'organization': 'University of Copenhagen'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Trained', 'description': 'Healthy, Endurance trained (VO2max, ml\\*min-1\\*kg-1\\>60), 20-30 year, BMI: 18,5-25kg/m2, males.', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Untrained', 'description': 'Healthy, sedentary (VO2max, ml\\*min-1\\*kg-1\\<50), 20-30 year, BMI: 18,5-25kg/m2, males.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incretin Effect (the % of Insulin Secreted Due to the Release of the Intestinal Hormones Glucagon Like Peptide-1 (GLP-1 and Glucose-dependent Insulinotropic Peptide (GIP))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trained', 'description': 'Healthy, Endurance trained (VO2max, ml\\*min-1\\*kg-1\\>60), 20-30 year, BMI: 18,5-25kg/m2, males.'}, {'id': 'OG001', 'title': 'Untrained', 'description': 'Healthy, sedentary (VO2max, ml\\*min-1\\*kg-1\\<50), 20-30 year, BMI: 18,5-25kg/m2, males.'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'spread': '4', 'groupId': 'OG000'}, {'value': '67', 'spread': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Test day 1 and 2 within 7 days.', 'description': 'The Incretin effect (the % of insulin secreted due to the release of the intestinal hormones GLP-1 and GIP) is calculated as the difference between the insulin concentration during a 3 hour oral glucose tolerance test (OGTT) (day 1) compared to a 3 hour isoglycemic intravenous glucose infusion (IIGI) (day 2) that has similar glucose excursions.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Total Glucose-dependent Insulinotropic Peptide (GIP) Response Measured as Area Under the GIP Curve (AUC GIP).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trained', 'description': 'Healthy, Endurance trained (VO2max, ml\\*min-1\\*kg-1\\>60), 20-30 year, BMI: 18,5-25kg/m2, males.'}, {'id': 'OG001', 'title': 'Untrained', 'description': 'Healthy, sedentary (VO2max, ml\\*min-1\\*kg-1\\<50), 20-30 year, BMI: 18,5-25kg/m2, males.'}], 'classes': [{'title': 'Post OGTT', 'categories': [{'measurements': [{'value': '3978', 'spread': '565', 'groupId': 'OG000'}, {'value': '3819', 'spread': '452', 'groupId': 'OG001'}]}]}, {'title': 'Post IIGI', 'categories': [{'measurements': [{'value': '692', 'spread': '103', 'groupId': 'OG000'}, {'value': '725', 'spread': '202', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Test day 1 and 2 within 7 days.', 'description': 'Comparison of the total release of GIP during the 3 hour OGTT and IIGI.', 'unitOfMeasure': 'pmol/L * 210 min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Trained', 'description': 'Healthy, Endurance trained (VO2max, ml\\*min-1\\*kg-1\\>60), 20-30 year, BMI: 18,5-25kg/m2, males.'}, {'id': 'FG001', 'title': 'Untrained', 'description': 'Healthy, sedentary (VO2max, ml\\*min-1\\*kg-1\\<50), 20-30 year, BMI: 18,5-25kg/m2, males.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Trained', 'description': 'Healthy, Endurance trained (Maximal oxygen uptake (VO2max), ml\\*min-1\\*kg-1\\>60), 20-30 year, BMI: 18,5-25kg/m2, males.'}, {'id': 'BG001', 'title': 'Untrained', 'description': 'Healthy, sedentary (Maximal oxygen uptake (VO2max), ml\\*min-1\\*kg-1\\<50), 20-30 year, BMI: 18,5-25kg/m2, males.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25', 'spread': '3', 'groupId': 'BG000'}, {'value': '25', 'spread': '3', 'groupId': 'BG001'}, {'value': '25', 'spread': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Denmark', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Human plasma samples.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-24', 'studyFirstSubmitDate': '2012-09-26', 'resultsFirstSubmitDate': '2013-12-10', 'studyFirstSubmitQcDate': '2012-09-28', 'lastUpdatePostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-24', 'studyFirstPostDateStruct': {'date': '2012-10-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incretin Effect (the % of Insulin Secreted Due to the Release of the Intestinal Hormones Glucagon Like Peptide-1 (GLP-1 and Glucose-dependent Insulinotropic Peptide (GIP))', 'timeFrame': 'Test day 1 and 2 within 7 days.', 'description': 'The Incretin effect (the % of insulin secreted due to the release of the intestinal hormones GLP-1 and GIP) is calculated as the difference between the insulin concentration during a 3 hour oral glucose tolerance test (OGTT) (day 1) compared to a 3 hour isoglycemic intravenous glucose infusion (IIGI) (day 2) that has similar glucose excursions.'}], 'secondaryOutcomes': [{'measure': 'The Total Glucose-dependent Insulinotropic Peptide (GIP) Response Measured as Area Under the GIP Curve (AUC GIP).', 'timeFrame': 'Test day 1 and 2 within 7 days.', 'description': 'Comparison of the total release of GIP during the 3 hour OGTT and IIGI.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Incretin', 'Training', 'Glucagon like peptide', 'glucose dependent insulinotropic peptide', 'Gut', 'Exercise', 'Insulin', 'Focus:', 'Gut hormone', 'adaptations'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '8271219', 'type': 'BACKGROUND', 'citation': 'Dela F, Handberg A, Mikines KJ, Vinten J, Galbo H. GLUT 4 and insulin receptor binding and kinase activity in trained human muscle. J Physiol. 1993 Sep;469:615-24. doi: 10.1113/jphysiol.1993.sp019833.'}, {'pmid': '1476187', 'type': 'BACKGROUND', 'citation': 'Dela F, Mikines KJ, von Linstow M, Secher NH, Galbo H. Effect of training on insulin-mediated glucose uptake in human muscle. Am J Physiol. 1992 Dec;263(6):E1134-43. doi: 10.1152/ajpendo.2006.263.6.E1134.'}, {'pmid': '2651385', 'type': 'BACKGROUND', 'citation': 'Mikines KJ, Sonne B, Farrell PA, Tronier B, Galbo H. Effect of training on the dose-response relationship for insulin action in men. J Appl Physiol (1985). 1989 Feb;66(2):695-703. doi: 10.1152/jappl.1989.66.2.695.'}, {'pmid': '1987787', 'type': 'BACKGROUND', 'citation': 'Dela F, Mikines KJ, Von Linstow M, Galbo H. Effect of training on response to a glucose load adjusted for daily carbohydrate intake. Am J Physiol. 1991 Jan;260(1 Pt 1):E14-20. doi: 10.1152/ajpendo.1991.260.1.E14.'}, {'pmid': '3325486', 'type': 'BACKGROUND', 'citation': 'King DS, Dalsky GP, Staten MA, Clutter WE, Van Houten DR, Holloszy JO. Insulin action and secretion in endurance-trained and untrained humans. J Appl Physiol (1985). 1987 Dec;63(6):2247-52. doi: 10.1152/jappl.1987.63.6.2247.'}, {'pmid': '2655469', 'type': 'BACKGROUND', 'citation': 'Mikines KJ, Sonne B, Tronier B, Galbo H. Effects of training and detraining on dose-response relationship between glucose and insulin secretion. Am J Physiol. 1989 May;256(5 Pt 1):E588-96. doi: 10.1152/ajpendo.1989.256.5.E588.'}, {'pmid': '4749457', 'type': 'BACKGROUND', 'citation': 'Dupre J, Ross SA, Watson D, Brown JC. Stimulation of insulin secretion by gastric inhibitory polypeptide in man. J Clin Endocrinol Metab. 1973 Nov;37(5):826-8. doi: 10.1210/jcem-37-5-826. No abstract available.'}, {'pmid': '3542566', 'type': 'BACKGROUND', 'citation': 'Holst JJ, Orskov C, Nielsen OV, Schwartz TW. Truncated glucagon-like peptide I, an insulin-releasing hormone from the distal gut. FEBS Lett. 1987 Jan 26;211(2):169-74. doi: 10.1016/0014-5793(87)81430-8.'}, {'pmid': '8423228', 'type': 'BACKGROUND', 'citation': 'Nauck MA, Heimesaat MM, Orskov C, Holst JJ, Ebert R, Creutzfeldt W. Preserved incretin activity of glucagon-like peptide 1 [7-36 amide] but not of synthetic human gastric inhibitory polypeptide in patients with type-2 diabetes mellitus. J Clin Invest. 1993 Jan;91(1):301-7. doi: 10.1172/JCI116186.'}, {'pmid': '22171657', 'type': 'BACKGROUND', 'citation': 'Knop FK, Aaboe K, Vilsboll T, Volund A, Holst JJ, Krarup T, Madsbad S. Impaired incretin effect and fasting hyperglucagonaemia characterizing type 2 diabetic subjects are early signs of dysmetabolism in obesity. Diabetes Obes Metab. 2012 Jun;14(6):500-10. doi: 10.1111/j.1463-1326.2011.01549.x. Epub 2012 Jan 17.'}]}, 'descriptionModule': {'briefSummary': "It is well known that continuous physical exercise leads to a number of changes in the body. Maximal oxygen uptake; the heart's pumping ability and muscle mass and strength increases. Also the metabolism adapts: The ability to oxidize fat increase and the insulin sensitivity in primarily in muscle, but also in the liver increase.\n\nAlso endocrine glands adapts according to the level of physical activity. It is known that in healthy, younger people the insulin secretion from the pancreas after administration of sugar consumed orally or given directly into a vein, is significantly lower in trained individuals compared with untrained. This change does, however, not only apply to glucose, as also stimulation by the amino acid arginine, shows the same pattern.\n\nIt seems plausible that the endocrine glands/cells adapts to the level of physical training, but this has not yet been investigated.\n\nThe gastrointestinal tract is the birthplace of a variety of hormones. One group of these is called incretin hormones. They stimulate the glucose dependant insulin secretion in the pancreas and affect hunger/satiety. Whether the incretin production and thus their concentration in the blood is regulated by physical training is unknown.\n\nObese and patients with type 2 diabetes, has, in contrast to well-trained, decreased insulin sensitivity. As a consequence their (type 2 diabetics, at least early in their disease course) meal stimulated insulin release is greater than in healthy, normal weight individuals. This in spite of the fact that the incretin effect is reduced in obese people and patients with type 2 diabetes compared to healthy, normal weight.\n\nWhether physical training affects both the secretion of incretins and the incretin effect has not yet been studied.\n\nThe purpose of this study is to investigate whether incretin hormones in physical well-trained young men have a changed effect on insulin secretion from the pancreas compared to untrained young men. A difference may indicate that the body's endocrine glands adapts to training mode.\n\nThe investigators hypothesis is that incretin hormones have a decreased effect on the glucose dependant insulin release in physically trained persons and thus results in a lower insulin release at any given plasma glucose level."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Danish University Students from University of Copenhagen,', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sedentary: 50\\>Maximal oxygen uptake (VO2max), ml\\*min-1\\*kg-1 OR endurance trained VO2max, ml\\*min-1\\*kg-1\\>60\n* 20-30 years\n* BMI: 18,5-25kg/m2\n* Caucasian\n* Healthy\n\nExclusion Criteria:\n\n* Any kind of medication or diabetes in the family (parents, siblings),\n* Non-caucasian'}, 'identificationModule': {'nctId': 'NCT01698502', 'acronym': 'EXINT2', 'briefTitle': 'Physical Training and the Incretin Effect', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Does Physical Training Effect the Incretin Effect', 'orgStudyIdInfo': {'id': 'EXINT2_FD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Trained', 'description': 'Healthy, Endurance trained (Maximal oxygen uptake (VO2max), ml\\*min-1\\*kg-1\\>60), 20-30 year, BMI: 18,5-25kg/m2, males.'}, {'label': 'Untrained', 'description': 'Healthy, sedentary (Maximal oxygen uptake (VO2max), ml\\*min-1\\*kg-1\\<50), 20-30 year, BMI: 18,5-25kg/m2, males.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2200', 'city': 'Copenhagen', 'state': 'North', 'country': 'Denmark', 'facility': 'University of Copenhagen, Faculty of Health Sciences', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Flemming Dela, Prof. MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Copenhagen, Dep. of Biomedical Sciences, Center of healthy Ageing, XLAB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD. PhD. Student', 'investigatorFullName': 'Michael Taulo Lund', 'investigatorAffiliation': 'University of Copenhagen'}}}}