Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-04-18 @ 12:54 AM
Study NCT ID:
NCT01884792
Status:
COMPLETED
Last Update Posted:
2014-09-15
First Post:
2013-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Standing on Glycemia in Prediabetic Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-12', 'studyFirstSubmitDate': '2013-06-19', 'studyFirstSubmitQcDate': '2013-06-21', 'lastUpdatePostDateStruct': {'date': '2014-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood sugar area under the curve', 'timeFrame': '2 hours', 'description': 'The area under the curve following the 2 hour blood sugar tests.'}], 'secondaryOutcomes': [{'measure': 'Accelerometer counts', 'timeFrame': '4 hours and 2 5 day periods', 'description': 'Accelerometer counts in the 4 testing conditions.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prediabetes', 'physical inactivity', 'sedentary', 'standing'], 'conditions': ['Prediabetes']}, 'descriptionModule': {'briefSummary': 'The study is a crossover, pilot trial examining the acute effects of standing on blood sugar in prediabetic, working adults. Participants will complete oral glucose tolerance testing, once while sitting and once while standing. They will also wear a continuous blood sugar monitor once while sitting at their desk for a week and once while using their desk as a sit-stand desk with a goal of standing intermittently for at least half of the work day. Physical activity levels will be measured with an accelerometer. The primary study hypothesis is that blood sugar will differ between the sitting and standing conditions for each of the tests performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fasting blood glucose \\>100 mg/dl\n* Employed full-time working at least 35 hours/week\n* Able to safely begin a light physical activity program\n\nExclusion Criteria:\n\n* Heart disease\n* Renal disease\n* Peripheral neuropathy\n* Retinopathy\n* PAD\n* Lower limb amputation\n* pregnancy\n* active substance abuse\n* current smoker\n* psychiatric disorder\n* severe visual impairment\n* immune-compromised individuals,\n* enrollment in a physical activity study\n* use of insulin or an insulin pump'}, 'identificationModule': {'nctId': 'NCT01884792', 'briefTitle': 'Effects of Standing on Glycemia in Prediabetic Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Acute Effects of Standing on Glycemia in Prediabetic Adults: A Pilot Study', 'orgStudyIdInfo': {'id': '1208M18741'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Sitting Oral Glucose Tolerance Test', 'description': 'An OGTT is performed while the subject sits at their desk for the entire 2-hour period. 5 blood sugar measurements are taken and a 75g dextrose beverage is consumed following the first, baseline blood sugar reading. The blood sugar is then measured every 30 minutes up to 120 min.', 'interventionNames': ['Other: Sitting OGTT', 'Other: Standing OGTT']}, {'type': 'EXPERIMENTAL', 'label': 'Standing Oral Glucose Tolerance Test', 'description': 'The participant stands at their desk for the duration of the 2-hour blood sugar test. The same procedure is performed as in the sitting condition.', 'interventionNames': ['Other: Sitting OGTT', 'Other: Standing OGTT']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sitting Continuous Glucose Monitor', 'description': 'A continuous blood glucose monitor is worn for 5 days while at work. In the sitting condition the participant only sits at their desk for the duration of the week. Blood sugar is monitored 4 times per day to calibrate the CGM and an accelerometer is worn to track physical activity.', 'interventionNames': ['Other: Sitting CGM', 'Other: Standing CGM']}, {'type': 'EXPERIMENTAL', 'label': 'Standing Continuous Glucose Monitor', 'description': 'Participants are instructed to stand intermittently for at least half of their work day during this 5 day period. Blood sugar is monitored and physical activity is tracked with an accelerometer.', 'interventionNames': ['Other: Sitting CGM', 'Other: Standing CGM']}], 'interventions': [{'name': 'Sitting OGTT', 'type': 'OTHER', 'armGroupLabels': ['Sitting Oral Glucose Tolerance Test', 'Standing Oral Glucose Tolerance Test']}, {'name': 'Standing OGTT', 'type': 'OTHER', 'armGroupLabels': ['Sitting Oral Glucose Tolerance Test', 'Standing Oral Glucose Tolerance Test']}, {'name': 'Sitting CGM', 'type': 'OTHER', 'armGroupLabels': ['Sitting Continuous Glucose Monitor', 'Standing Continuous Glucose Monitor']}, {'name': 'Standing CGM', 'type': 'OTHER', 'armGroupLabels': ['Sitting Continuous Glucose Monitor', 'Standing Continuous Glucose Monitor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55155', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Department of Human Services', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mayo Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}