Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT01748305
Status:
TERMINATED
Last Update Posted:
2015-10-23
First Post:
2012-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Moderate-to-vigorous Physical Activity for Glycemic Control in Patients With Gestational Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'Recruitment issues.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-22', 'studyFirstSubmitDate': '2012-12-10', 'studyFirstSubmitQcDate': '2012-12-11', 'lastUpdatePostDateStruct': {'date': '2015-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need for medication for diabetes', 'timeFrame': '3 weeks'}], 'secondaryOutcomes': [{'measure': 'Birth weight', 'timeFrame': 'delivery'}, {'measure': 'A1c', 'timeFrame': 'delivery'}, {'measure': 'Mode of delivery', 'timeFrame': 'delivery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GDM', 'A1GDM', 'A2GDM'], 'conditions': ['Gestational Diabetes Mellitus', 'Exercise']}, 'descriptionModule': {'briefSummary': 'Patients with newly diagnosed gestational diabetes will be recruited. The control group with get routine diet and exercise counseling. The intervention group will be instructed to get moderate-to-vigorous intensity exercise; they will walk on a treadmill one time with supervision in order to be instructed how hard to work. All participants will keep an exercise log for 3 weeks and will wear an accelerometer for 1 week. The primary outcome is glucose control, specifically the need for medication in treatment of their diabetes. The hypothesis is that moderate or greater intensity exercise will better control glucose and lead to less need for medication management.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gestational diabetes mellitus\n* singelton pregnancy\n* 18 years old or older\n* no medical contraindications to exercise\n\nExclusion Criteria:\n\n* multiple gestation\n* non-English speaking\n* unable to exercise\n* preexisting diabetes'}, 'identificationModule': {'nctId': 'NCT01748305', 'briefTitle': 'Moderate-to-vigorous Physical Activity for Glycemic Control in Patients With Gestational Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Moderate-to-vigorous Physical Activity for Glycemic Control in Patients With Gestational Diabetes Mellitus: a Pilot Study', 'orgStudyIdInfo': {'id': 'e8631'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moderate-to-vigorous intensity exercise', 'description': 'Moderate-to-vigorous intensity exercise three times per day for three weeks', 'interventionNames': ['Behavioral: Moderate-to-vigorous intensity exercise']}], 'interventions': [{'name': 'Moderate-to-vigorous intensity exercise', 'type': 'BEHAVIORAL', 'description': 'Moderate-to-vigorous intensity exercise three times per day for three weeks', 'armGroupLabels': ['Moderate-to-vigorous intensity exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Antonio Frias, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}, {'name': 'Jessica Voge, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MFM', 'investigatorFullName': 'Antonio E. Frias', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}