Viewing Study NCT02180620


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Study NCT ID: NCT02180620
Status: COMPLETED
Last Update Posted: 2017-06-08
First Post: 2014-06-30
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Pre-dinner vs. Post-dinner Exercise on Glycemic Control
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', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-06', 'studyFirstSubmitDate': '2014-06-30', 'studyFirstSubmitQcDate': '2014-07-01', 'lastUpdatePostDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'GLP-1 concentrations', 'timeFrame': 'Blood samples were taken every 5-10 min during the first 3.7 h of testing and every 30 min during the last 2 h'}], 'primaryOutcomes': [{'measure': 'glucose concentrations', 'timeFrame': 'Blood samples were taken every 5-10 min during the first 3.7 h of testing and every 30 min during the last 2 h'}], 'secondaryOutcomes': [{'measure': 'triglyceride concentrations', 'timeFrame': 'Blood samples were taken every 5-10 min during the first 3.7 h of testing and every 30 min during the last 2 h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GIP', 'GLP-1', 'exercise timing', 'resistance exercise', 'glucose concentrations'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '28970202', 'type': 'DERIVED', 'citation': 'Heden TD, Liu Y, Kanaley JA. A comparison of adipose tissue interstitial glucose and venous blood glucose during postprandial resistance exercise in patients with type 2 diabetes. J Appl Physiol (1985). 2018 Apr 1;124(4):1054-1061. doi: 10.1152/japplphysiol.00475.2017. Epub 2017 Sep 28.'}]}, 'descriptionModule': {'briefSummary': 'With many medications we prescribe them relative to time of day or a meal. This study established if pre dinner vs post dinner exercise was more effective at altering post dinner glucose and triglyceride levels vs no exercise at all.', 'detailedDescription': 'All participants completed three trials in a random order in which they consumed a standardized dinner meal with 1) no RE (NoRE), 2) pre-dinner RE (RE→M), and 3) post-dinner RE beginning 45 min after dinner (M→RE). Diet was standardized during the day of testing. Participants reported to the lab for testing sometime between 3 - 5:30 p.m. and upon arrival a venous catheter was inserted into a forearm vein. Frequent blood sampling, indirect calorimetry measurements, and subjective well-being measurements ensued for \\~5.75 h while the participants were in the lab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obese ( body mass index 30-45 kg/m2)\n* Physician diagnosed with type 2 diabetes receiving standard medical care\n* Non-smokers\n* Pregnancy\n* Lactating mothers\n\nExclusion Criteria:\n\n* Insulin\n* Surgical weight loss\n* Orthopedic limitations to exercise\n* Weight loss in the previous 3 months'}, 'identificationModule': {'nctId': 'NCT02180620', 'briefTitle': 'Pre-dinner vs. Post-dinner Exercise on Glycemic Control', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Exercise Timing and Postprandial Glycemia in Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'exertime'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'No exercise', 'description': 'participants will remain sedentary during testing', 'interventionNames': ['Other: No exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Meal then exercise', 'description': '45 min of resistance training will be performed after a standard meal', 'interventionNames': ['Other: Meal then exercise']}, {'type': 'EXPERIMENTAL', 'label': 'exercise then meal', 'description': '45 min of resistance training will be performed prior to a standard meal', 'interventionNames': ['Other: exercise then meal']}], 'interventions': [{'name': 'No exercise', 'type': 'OTHER', 'otherNames': ['NoEX'], 'description': 'During the no exercise trial (NoEX), the participants will remain sedentary during testing.', 'armGroupLabels': ['No exercise']}, {'name': 'Meal then exercise', 'type': 'OTHER', 'otherNames': ['M-EX'], 'description': 'During the post-meal exercise trial (M→EX), 45 min of resistance training will be performed', 'armGroupLabels': ['Meal then exercise']}, {'name': 'exercise then meal', 'type': 'OTHER', 'otherNames': ['EX-M'], 'description': 'During the exercise prior to the meal trial (EX→M), 45 min of resistance training will be performed', 'armGroupLabels': ['exercise then meal']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Jill Kanaley', 'investigatorAffiliation': 'University of Missouri-Columbia'}}}}