Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2025-12-28 @ 5:38 PM
Study NCT ID:
NCT01580761
Status:
COMPLETED
Last Update Posted:
2022-01-21
First Post:
2012-04-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Restriction and Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-18', 'studyFirstSubmitDate': '2012-04-17', 'studyFirstSubmitQcDate': '2012-04-17', 'lastUpdatePostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in caloric intake and hunger', 'timeFrame': 'baseline to 21 days', 'description': 'Change in caloric intake and hunger, measured during acclimation, experimental and recovery timepoints.'}, {'measure': 'Change in energy expenditure', 'timeFrame': 'baseline to 21 days', 'description': 'Change in energy expenditure, including activity energy expenditure, thermic effect of food (TEF), and basal metabolic rate (BMR), measured during acclimation, experimental and recovery timepoints..'}, {'measure': 'Change in fat tissue characteristics and body composition', 'timeFrame': 'baseline to 21 days', 'description': 'Changes in fat tissue characteristics from serial fat biopsies, and in body composition from DEXA and CT imaging, measured during acclimation, experimental and recovery timepoints.'}, {'measure': 'Change in metabolic hormones', 'timeFrame': 'baseline to 21 days', 'description': 'Change in metabolic hormones measured during acclimation, experimental and recovery timepoints.'}], 'secondaryOutcomes': [{'measure': 'Change in neurocognitive deficits', 'timeFrame': 'baseline to 21 days', 'description': 'Change in neurocognitive function measured by battery, measured during acclimation, experimental and recovery timepoints..'}, {'measure': 'Change in blood pressure and autonomic function', 'timeFrame': 'baseline to 21 days', 'description': 'Change in mean arterial blood pressure and autonomic function, measured during acclimation, experimental and recovery timepoints.'}, {'measure': 'Change in markers of inflammation and endothelial function', 'timeFrame': 'baseline to 21 days', 'description': 'Change in markers of inflammation and endothelial function, measured during acclimation, experimental and recovery timepoints.'}, {'measure': 'Change in electrocardiographic characteristics', 'timeFrame': 'baseline to 21 days', 'description': 'Change in electrocardiographic characteristics, measured during acclimation, experimental and recovery timepoints.'}, {'measure': 'Change in arterial stiffness', 'timeFrame': 'baseline to 21 days', 'description': 'Change in arterial stiffness, measured during acclimation, experimental, and recovery timepoints.'}, {'measure': 'Change in cardiovascular reactivity', 'timeFrame': 'baseline to 21 days', 'description': 'Change in cardiovascular reactivity, measured during acclimation, experimental, and recovery timepoints.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '35361348', 'type': 'DERIVED', 'citation': 'Covassin N, Singh P, McCrady-Spitzer SK, St Louis EK, Calvin AD, Levine JA, Somers VK. Effects of Experimental Sleep Restriction on Energy Intake, Energy Expenditure, and Visceral Obesity. J Am Coll Cardiol. 2022 Apr 5;79(13):1254-1265. doi: 10.1016/j.jacc.2022.01.038.'}], 'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Insufficient sleep may be one of the most common, and most preventable, obesity risk factors. The investigators wish to determine whether 14 nights of modest sleep restriction results in increased energy balance, thus potentially increasing the risk of obesity. The investigators hypothesize that sleep restriction will result in increased energy balance.', 'detailedDescription': 'Numerous studies have reported that self-reported short sleep duration is associated with obesity and weight gain. Insufficient sleep may be one of the most common, and most preventable, obesity risk factors. Given that sleep restriction is largely voluntary and potentially correctable, understanding the mechanisms that link insufficient sleep to positive energy balance and the development of obesity, particularly visceral obesity, is crucial to clinical applications, public health policy, and informing future studies. The investigators wish to determine whether 14 nights of modest sleep restriction results in increased energy balance, thus potentially increasing the risk of obesity. The investigators will combine energy balance, biomarker, and imaging data with state-of-the art sleep monitoring to provide unambiguous data on the effects of sleep restriction on obesity. Together, the investigators findings will help explain whether the reduced sleep duration in the general population may be contributing to the current epidemic of obesity, and suggest strategies to reduce this risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-40 years\n* BMI of 18.5-30 kg/m2\n* Not a current smoker or tobacco user\n* No chronic medical or psychiatric disorders\n* On no prescription medications other than second generation antihistamines (cetirizine, fexofenadine, desloratadine, loratadine, etc), oral contraceptive pills, or intrauterine devices\n* History of normal sleep patterns, defined as nocturnal sleep duration of 6.5-8 hours per night without regular daytime naps\n\nExclusion Criteria:\n\n* The investigators will exclude subjects who have any medical or psychiatric disorders\n* History of anxiety or depression\n* Those taking any medications other than non-sedating antihistamines or oral contraceptives will be excluded\n* Those found to have depression on a depression screening tool (BDI-II) will be excluded\n* Current smokers will be excluded\n* All female subjects will undergoing a screening pregnancy test and excluded if positive\n* Subjects found to have significant sleep disorders will be excluded'}, 'identificationModule': {'nctId': 'NCT01580761', 'briefTitle': 'Sleep Restriction and Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Sleep Restriction and Obesity', 'orgStudyIdInfo': {'id': '11-007272'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sleep restriction', 'description': 'Sleep restriction', 'interventionNames': ['Behavioral: Sleep restriction']}, {'type': 'NO_INTERVENTION', 'label': 'Normal sleep', 'description': 'Normal sleep'}], 'interventions': [{'name': 'Sleep restriction', 'type': 'BEHAVIORAL', 'description': '14 days of sleep restriction, 4 hours of sleep per day.', 'armGroupLabels': ['Sleep restriction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Virend Somers, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Virend Somers, MD, PhD', 'investigatorAffiliation': 'Mayo Clinic'}}}}