Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT04846751
Status:
UNKNOWN
Last Update Posted:
2022-11-04
First Post:
2021-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise Type That Faster Reduces Postprandial Glycemia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C538376', 'term': 'Hyperinsulinemic hypoglycemia, familial, 7'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Study composed of 4 trials, full-crossover, administered in a randomized order with the inclusion of a control trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 11}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2024-09-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-03', 'studyFirstSubmitDate': '2021-04-11', 'studyFirstSubmitQcDate': '2021-04-14', 'lastUpdatePostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood glucose concentration', 'timeFrame': '16 weeks', 'description': 'Incremental area under the curve during the 120 min of the oral glucose tolerance test'}, {'measure': 'Blood insulin concentration', 'timeFrame': '16 weeks', 'description': 'Incremental area under the curve during the 120 min of the oral glucose tolerance test'}], 'secondaryOutcomes': [{'measure': 'Carbohydrate oxidation', 'timeFrame': '16 weeks', 'description': 'Measured using indirect calorimetry'}, {'measure': 'Turnover rate of endogenous and exogenous glucose', 'timeFrame': '16 weeks', 'description': 'Measured using isotopic tracers.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glucose, High Blood', 'Exercise-Induced Hyperinsulinism']}, 'descriptionModule': {'briefSummary': 'It is well established that a bout of 50 min of continuous moderate intensity exercise, improves insulin sensitivity up to 48 hours after the bout. However, it is less well known, what is the exercise type more efficient to buffer the elevations in blood glucose elicited by carbohydrate ingestion. The purpose of this study is to elucidate if intervalic exercise is superior to continous on improving postprandial glycemic control.', 'detailedDescription': 'Carbohydrate oxidation, glucose and insulin blood concentrations, isotopically measured rate of appearance of endogenous and exogenous glucose will be measured in 4 ocassions.\n\nParticipants will undergo in a cross-over randomized fashion the following trials:\n\n1. Exercise pedalling during 50 min at 60% of their VO2max followed by an oral glucose tolerance test (OGTT).\n2. Exercise pedalling during 50 min in a hot environment (33ºC) at 60% of their VO2max followed by an oral glucose tolerance test (OGTT).\n3. Exercise pedalling during 50 min using intervalic bouts averaging 60% of VO2max followed by an oral glucose tolerance test (OGTT).\n4. No exercise, followed by an oral glucose tolerance test (OGTT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant must be capable and willing to provide consent, understand, instructions and protocols.\n* Minimal fitness level to be able to complete 50 min of continous exercise at a moderate intensity.\n\nExclusion Criteria:\n\n* Smokers\n* Pregnancy\n* Any non-controlled medical condition which could influence results or could be worsened by exercise'}, 'identificationModule': {'nctId': 'NCT04846751', 'acronym': 'GLYEXER', 'briefTitle': 'Exercise Type That Faster Reduces Postprandial Glycemia.', 'organization': {'class': 'OTHER', 'fullName': 'University of Castilla-La Mancha'}, 'officialTitle': 'Exercise Type That Faster Reduces Postprandial Glycemia.', 'orgStudyIdInfo': {'id': 'PID2020-116159RB-I00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'AEROBIC EXERCISE', 'description': '50 min of aerobic exercise by pedaling a cycleergometer at 60% of VO2max', 'interventionNames': ['Behavioral: TYPE OF EXERCISE (OR REST)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PLACEBO REST', 'description': 'No exercise, resting during 50 min.', 'interventionNames': ['Behavioral: TYPE OF EXERCISE (OR REST)']}], 'interventions': [{'name': 'TYPE OF EXERCISE (OR REST)', 'type': 'BEHAVIORAL', 'description': 'continous exercise in normal temperature, continous exercise in hot environment, intervallic exercise in normal temperature.', 'armGroupLabels': ['AEROBIC EXERCISE', 'PLACEBO REST']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45071', 'city': 'Toledo', 'country': 'Spain', 'facility': 'University of Castilla-La Mancha (Exercise Physiology Lab)', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}], 'overallOfficials': [{'name': 'Ricardo Mora-Rodriguez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Castilla-La Mancha'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be shared upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Castilla-La Mancha', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Exercise Lab at Toledo', 'investigatorFullName': 'Ricardo Mora', 'investigatorAffiliation': 'University of Castilla-La Mancha'}}}}