Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-07 @ 6:24 PM
Study NCT ID:
NCT02134860
Status:
COMPLETED
Last Update Posted:
2014-09-22
First Post:
2014-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bed Rest, Alternate Daily Fasting and Incretin Effect
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001510', 'term': 'Bed Rest'}, {'id': 'D005951', 'term': 'Glucose Tolerance Test'}, {'id': 'D009483', 'term': 'Neuropsychological Tests'}, {'id': 'D015502', 'term': 'Absorptiometry, Photon'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D003720', 'term': 'Densitometry'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-19', 'studyFirstSubmitDate': '2014-04-29', 'studyFirstSubmitQcDate': '2014-05-08', 'lastUpdatePostDateStruct': {'date': '2014-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incretin effect', 'timeFrame': '24 weeks', 'description': 'Measured by Insulin levels during Oral glucose tolerance test (OGTT) and Intravenous glucose tolerance test (IVGTT)'}, {'measure': 'Cognitive function', 'timeFrame': '18 months', 'description': 'Evaluated by cognitive testing and functional Magnetic Resonance imaging (MRI)'}, {'measure': 'Insulin resistance', 'timeFrame': '12 weeks', 'description': 'Evaluated by insulin resistance indexes, HOMA-IR and Matsuda index'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metabolic Syndrome', 'Type 2 Diabetes', 'Critical Illness']}, 'referencesModule': {'references': [{'pmid': '33512717', 'type': 'DERIVED', 'citation': 'Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.'}]}, 'descriptionModule': {'briefSummary': 'Bed rest produces insulin resistance in healthy volunteers. In this study the investigators aim to investigate the effect of 8 days bed rest on the incretin effect and how alternate daily fasting affects cognitive function and the insulin resistance produced by bed rest.\n\nThe subjects will be randomized to either 3 meals a day (isocaloric diet), alternate daily fasting or one meal/day every second day (25% of daily calorie need) and four meals/day every second (175% of daily calorie need).\n\nThe investigators hypothesize:\n\n1. Bed rest reduces the incretin effect\n2. Alternate daily fasting improves the cognitive function (memory and concentration) compared to isocaloric diet\n3. Alternate daily fasting reduces insulin resistance produced by bed rest compared to isocaloric diet', 'detailedDescription': 'All subjects will undergo 8 days of bedrest. Outcome measures will be performed before, under and immediately after the bed rest period.\n\nThe individual study period will be 10 days in total.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI\\<25kg/m2\n* VO2 max normal for age\n\nExclusion Criteria:\n\n* Tobacco smoking\n* Alcohol ingestion \\> 14 units per week\n* Diabetes in nearby relatives\n* Resection of the small intestine\n* History of gastric bypass surgery\n* Risk of deep venous thrombosis\n* Female'}, 'identificationModule': {'nctId': 'NCT02134860', 'briefTitle': 'Bed Rest, Alternate Daily Fasting and Incretin Effect', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'A Randomized Controlled Study on the Incretin Effect, Cognitive Function and Controlled Fasting During Bed Rest in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'H-6-2014-017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Isocaloric diet', 'description': '3 daily meals', 'interventionNames': ['Other: Bed rest', 'Other: OGTT', 'Other: IVGTT', 'Other: Cognitive testing', 'Other: Muscle and fat biopsies', 'Other: Dual-energy X-ray Absorptiometry (DXA) scan', 'Other: MRI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alternate daily fasting', 'description': 'One meal (25% of caloric need) every second day and four meals (175% of caloric need) every second day', 'interventionNames': ['Other: Bed rest', 'Other: OGTT', 'Other: IVGTT', 'Other: Cognitive testing', 'Other: Muscle and fat biopsies', 'Other: Dual-energy X-ray Absorptiometry (DXA) scan', 'Other: MRI']}], 'interventions': [{'name': 'Bed rest', 'type': 'OTHER', 'description': '8 days of full bed rest', 'armGroupLabels': ['Alternate daily fasting', 'Isocaloric diet']}, {'name': 'OGTT', 'type': 'OTHER', 'description': 'Oral glucose tolerance test with 75 g of glucose before and after bed rest', 'armGroupLabels': ['Alternate daily fasting', 'Isocaloric diet']}, {'name': 'IVGTT', 'type': 'OTHER', 'description': 'Intravenous glucose tolerance test mimicking the glucose profile from the corresponding OGTT', 'armGroupLabels': ['Alternate daily fasting', 'Isocaloric diet']}, {'name': 'Cognitive testing', 'type': 'OTHER', 'description': 'Daily testing of memory and concentration using standardized tests', 'armGroupLabels': ['Alternate daily fasting', 'Isocaloric diet']}, {'name': 'Muscle and fat biopsies', 'type': 'OTHER', 'description': 'Biopsies will be obtained before and after bed rest', 'armGroupLabels': ['Alternate daily fasting', 'Isocaloric diet']}, {'name': 'Dual-energy X-ray Absorptiometry (DXA) scan', 'type': 'OTHER', 'description': 'DXA scan to evaluate fat and muscle distribution before and after bed rest', 'armGroupLabels': ['Alternate daily fasting', 'Isocaloric diet']}, {'name': 'MRI', 'type': 'OTHER', 'description': 'Functional MRI to evaluate cognitive function and abdominal MRI to evaluate visceral fat before and after bed rest', 'armGroupLabels': ['Alternate daily fasting', 'Isocaloric diet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Nina Majlund Harder-Lauridsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, 7641'}, {'name': 'Signe Tellerup Nielsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, 7641'}, {'name': 'Rikke Krogh-Madsen, MD. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, 7641'}, {'name': 'Bente Klarlund Pedersen, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rigshospitalet, 7641'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Anders Rasmussen Rinnov', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}