Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-02-11 @ 10:35 PM
Study NCT ID:
NCT01872533
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2013-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of 10-day Overnight Hypoxia Treatment on Whole Body Insulin Sensitivity (SLEEP HIGH Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-01', 'studyFirstSubmitDate': '2013-06-03', 'studyFirstSubmitQcDate': '2013-06-05', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Insulin sensitivity', 'timeFrame': 'Change from baseline to 10 nights of hypoxia exposure', 'description': 'Glucose disposal and oxidation were measured using a two-step hyperinsulinemic euglycemic clamp and indirect calorimetry.'}], 'secondaryOutcomes': [{'measure': 'Change in oxygen tension in adipose tissue', 'timeFrame': 'Before and after 10 nights of hypoxia exposure', 'description': 'pO2 levels were measured in adipose tissue both under hypoxia and normal oxygen conditions (normoxia) via a dual temperature-oxygen tension probe.'}, {'measure': 'Glucose uptake in myotubes', 'timeFrame': 'Before 10 nights of hypoxia exposure', 'description': 'Glucose uptake assays were performed in the presence or absence of hypoxia on myotubes harvested from muscle biopsies.'}, {'measure': 'Change in gene and protein expression', 'timeFrame': 'Before and after 10 nights of hypoxia exposure', 'description': 'Gene and protein expression of some hypoxia-responsive and insulin-signaling markers were measured in biopsied muscle and adipose tissue via RT-PCR and Western blotting, respectively.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obesity', 'hypoxia', 'insulin sensitivity', 'altitude'], 'conditions': ['Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '24265370', 'type': 'DERIVED', 'citation': 'Lecoultre V, Peterson CM, Covington JD, Ebenezer PJ, Frost EA, Schwarz JM, Ravussin E. Ten nights of moderate hypoxia improves insulin sensitivity in obese humans. Diabetes Care. 2013 Dec;36(12):e197-8. doi: 10.2337/dc13-1350. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to look at how a reduction in oxygen levels (hypoxia) influences insulin sensitivity and carbohydrate metabolism. It is expected that 10 nights of exposure to moderate hypoxia (\\~ 15% O2, similar to conditions at an altitude of \\~7500 feet) will improve glucose metabolism.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 20-45 years\n* Male\n* Obese category (BMI \\> 30 kg/m2)\n* Healthy as assessed by a self-reported health questionnaire\n* Non-smokers\n* Weight stable over the past 3 months (\\<2kg fluctuation)\n\nExclusion Criteria:\n\n* Female\n* Diabetes\n* Sleep apnea\n* Hypertension\n* History of altitude sickness\n* Individuals taking any chronic medications\n* Individuals taking any stimulants\n* Individuals taking beta-blockers\n* Individuals with chronic alcohol consumption (\\>3 drinks per day) or drug abuse.\n* Individuals unable to abstain from caffeinated beverage or alcohol the days of study testing\n* Individuals with history disease or history of stroke'}, 'identificationModule': {'nctId': 'NCT01872533', 'acronym': 'SLEEP HIGH', 'briefTitle': 'Effect of 10-day Overnight Hypoxia Treatment on Whole Body Insulin Sensitivity (SLEEP HIGH Study)', 'organization': {'class': 'OTHER', 'fullName': 'Pennington Biomedical Research Center'}, 'officialTitle': 'Effect of 10-day Overnight Hypoxia Treatment on Whole Body Insulin Sensitivity (SLEEP HIGH Study)', 'orgStudyIdInfo': {'id': 'PBRC 11009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypoxia Exposure', 'description': 'There was only one study arm: All participants slept in moderate hypoxia (see description below).', 'interventionNames': ['Other: Hypoxia Exposure']}], 'interventions': [{'name': 'Hypoxia Exposure', 'type': 'OTHER', 'description': 'Participants spent 10 consecutive nights (approximately 100 hours of exposure) in a hypoxic tent at \\~ 15% O2 (ca. 2400 m elevation).', 'armGroupLabels': ['Hypoxia Exposure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eric Ravussin', 'investigatorAffiliation': 'Pennington Biomedical Research Center'}}}}