Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-28 @ 11:49 PM
Study NCT ID:
NCT03331432
Status:
COMPLETED
Last Update Posted:
2018-02-19
First Post:
2017-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Dietary Supplement Tauroursodeoxycholic Acid on Vascular Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C031655', 'term': 'ursodoxicoltaurine'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants are not told which are placebo or tauroursodeoxycholic acid capsules'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Single-blinded randomized crossover study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-14', 'studyFirstSubmitDate': '2017-10-26', 'studyFirstSubmitQcDate': '2017-10-31', 'lastUpdatePostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood flow', 'timeFrame': 'Once at 4 weeks after the start of placebo and once at 4 weeks after the start of tauroursodeoxycholic acid', 'description': 'Blood flow response during insulin clamp'}, {'measure': 'Vascular function', 'timeFrame': 'Once at 4 weeks after the start of placebo and once at 4 weeks after the start of tauroursodeoxycholic acid', 'description': 'Flow-mediated dilation'}, {'measure': 'Insulin resistance', 'timeFrame': 'Once at 4 weeks after the start of placebo and once at 4 weeks after the start of tauroursodeoxycholic acid', 'description': 'Glucose disposal rate during insulin clamp'}, {'measure': 'Glucose tolerance', 'timeFrame': 'Once at 4 weeks after the start of placebo and once at 4 weeks after the start of tauroursodeoxycholic acid', 'description': 'Glucose response to an oral glucose tolerance test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of the present study is to determine if use of dietary supplement tauroursodeoxycholic acid enhances insulin-stimulated leg blood flow and glucose disposal.', 'detailedDescription': 'The notion that cellular stress lowers insulin-induced vasodilation is largely founded on ex vivo studies and experiments in rodents. However, it remains unknown if maintenance of cellular function with the use of dietary supplement tauroursodeoxycholic acid enhances vascular function in humans. The investigators test the hypothesis that daily administration of this dietary supplement enhances vascular function, particularly, insulin-stimulated leg blood flow and glucose disposal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes diagnosed by primary physician\n* Body mass index less then 43 kg/m2\n\nExclusion Criteria:\n\n* Recent weight gain or loss (\\>5% body weight in the last 3 months)\n* Pregnancy\n* Consumption of \\>14 alcoholic beverages per week\n* Changes in the medication use or dose within the last 3 months\n* Known cardiovascular or pulmonary disease\n* Taking medication for advanced retinopathy or neuropathy\n* Taking prescription anticoagulants\n* Nicotine use'}, 'identificationModule': {'nctId': 'NCT03331432', 'briefTitle': 'Effects of Dietary Supplement Tauroursodeoxycholic Acid on Vascular Function', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Targeting Endoplasmic Reticulum Stress to Correct Vascular Insulin Resistance and Glycemic Dysregulation', 'orgStudyIdInfo': {'id': '1203573'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Taking daily placebo capsules for 4 weeks', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Tauroursodeoxycholic acid', 'description': 'Taking tauroursodeoxycholic acid (1750 mg/day) capsules for 4 weeks', 'interventionNames': ['Dietary Supplement: Tauroursodeoxycholic acid']}], 'interventions': [{'name': 'Tauroursodeoxycholic acid', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Taking tauroursodeoxycholic acid (1750 mg/day) capsules for 4 weeks.', 'armGroupLabels': ['Tauroursodeoxycholic acid']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Taking daily placebo capsules for 4 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65211', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'Jaume Padilla, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri-Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jaume Padilla', 'investigatorAffiliation': 'University of Missouri-Columbia'}}}}