Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-24 @ 5:17 PM
Study NCT ID:
NCT02583750
Status:
COMPLETED
Last Update Posted:
2015-10-22
First Post:
2015-10-15
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Snooze Control: Sleep Duration & Glucose Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D012892', 'term': 'Sleep Deprivation'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-20', 'studyFirstSubmitDate': '2015-10-15', 'studyFirstSubmitQcDate': '2015-10-20', 'lastUpdatePostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose concentrations during oral glucose tolerance test', 'timeFrame': 'two hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glucose metabolism', 'sleep deprivation'], 'conditions': ['Glucose Metabolism Disorders']}, 'descriptionModule': {'briefSummary': 'This project investigated how glucose metabolism differs due to sleep deprivation for three consecutive nights as compared to sufficient sleep for three nights by examining concentrations of glucose, insulin, and other factors involved in glucose metabolism.', 'detailedDescription': "16 participants were enrolled in the study (8 females, 8 males) aged 18-25 years. In order for the participants to qualify for the study, each had to wear a pedometer for a week before the study began to determine eligibility. Each participant came to the lab for an oral glucose tolerance test on a morning, following three nights when they were sleep deprived, and on another morning when they had three nights' sufficient sleep. The sequence of the oral glucose tolerance tests were randomly assigned. The sleep duration for participants was monitored by the readings of the sleep monitors that each participant wore. The oral glucose tolerance tests were performed after an overnight fast. A 20-gauge polyethylene catheter was placed in the antecubital vein for blood sampling. Blood samples were drawn once (0 min) before and 4 times (30, 60, 90, and 120 min) after a 75g glucose drink was consumed for the determination of plasma glucose, insulin, and concentrations of other factors. Each participant was told to continue their regular routine during the study period, including diet, caffeine usage, and exercise."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy college-aged males and females\n* being minimally active\n\nExclusion Criteria:\n\n* average more than 15,000 steps a day\n* major health issues such as heart disease, diabetes\n* taking medication to help with sleep or using a sleeping device\n* any type of sleep problem such as sleep apnea'}, 'identificationModule': {'nctId': 'NCT02583750', 'briefTitle': 'Snooze Control: Sleep Duration & Glucose Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'University of South Carolina'}, 'officialTitle': 'Snooze Control: The Effect of Sleep Deprivation on Glucose Metabolism', 'orgStudyIdInfo': {'id': 'Pro00032421'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OGTT after deprived sleep first', 'description': 'Participants came to the lab to perform the oral glucose tolerance test after three nights of sleep deprivation, then another test after three nights of sufficient sleep', 'interventionNames': ['Behavioral: OGTT after deprived sleep first']}, {'type': 'EXPERIMENTAL', 'label': 'OGTT after sufficient sleep first', 'description': 'Participants came to the lab to perform the oral glucose tolerance test after three nights of sufficient sleep, then another test after three nights of deprived sleep', 'interventionNames': ['Behavioral: OGTT after sufficient sleep first']}], 'interventions': [{'name': 'OGTT after deprived sleep first', 'type': 'BEHAVIORAL', 'description': 'Participants slept 1-3 hours less than their normal amount for three nights, and then came to the lab for the oral glucose tolerance testing after a 12 hour overnight fast. The second oral glucose tolerance test was after they slept as much as they wanted for three nights.', 'armGroupLabels': ['OGTT after deprived sleep first']}, {'name': 'OGTT after sufficient sleep first', 'type': 'BEHAVIORAL', 'description': 'Participants slept as much as they wanted for three nights, and then came to the lab for the oral glucose tolerance testing after a 12 hour overnight fast. The second oral glucose tolerance test was after they slept 1-3 hours less than normal for three nights.', 'armGroupLabels': ['OGTT after sufficient sleep first']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29201', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Public Health Research Center University of South Carolina', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}], 'overallOfficials': [{'name': 'Xuewen Wang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuewen Wang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr. Xuewen Wang, PhD.', 'investigatorFullName': 'Xuewen Wang', 'investigatorAffiliation': 'University of South Carolina'}}}}