Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-03-01 @ 4:39 AM
Study NCT ID:
NCT02518334
Status:
COMPLETED
Last Update Posted:
2017-10-26
First Post:
2012-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wine Consumption and Glycemic Control
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': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-24', 'studyFirstSubmitDate': '2012-02-08', 'studyFirstSubmitQcDate': '2015-08-04', 'lastUpdatePostDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral glucose tolerance test', 'timeFrame': '3 weeks', 'description': 'Measurement of blood glucose taken every 15 minutes over a course of three hours.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['type two diabetes', 'glycemic control'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '15161790', 'type': 'BACKGROUND', 'citation': "Avogaro A, Watanabe RM, Dall'Arche A, De Kreutzenberg SV, Tiengo A, Pacini G. Acute alcohol consumption improves insulin action without affecting insulin secretion in type 2 diabetic subjects. Diabetes Care. 2004 Jun;27(6):1369-74. doi: 10.2337/diacare.27.6.1369."}]}, 'descriptionModule': {'briefSummary': "Many studies have reported that alcoholic beverage consumption, especially in the form of wine, reduces the risk of developing type 2 diabetes by as much as 40%. This association suggests that wine consumption may somehow improve the body's ability to control its blood glucose concentration. Indeed, it has been reported that when wine is consumed immediately prior to ingestion of glucose, the release of insulin is enhanced and blood glucose concentration is lowered. The mechanism of wine's effects on blood glucose concentration is unknown, but is likely related to its ethanol or antioxidant content. In this study, the investigators plan to test whether wine or plain ethanol (vodka) ingestion alters the control of blood glucose in subjects who have diabetes or pre-diabetes.", 'detailedDescription': "Our central hypothesis is that improvement in glycemic control by acute consumption of wine is mediated by ethanol. Subjects will have type 2 diabetes, pre-diabetes, and be sedentary and obese (BMI \\>30). Subjects' glycemic control will be assessed by an oral glucose tolerance test (OGTT) at three different time points. One OGTT will occur shortly after consumption of red wine, the second after consumption of vodka containing the identical amount of ethanol as the wine treatment, and the third OGTT will occur shortly after consumption of an equal volume of water. The three OGTTs will be administered in random order."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* insulin resistant: diagnosed with pre-diabetes or fasting blood glucose \\>/= 97 mg/dL\n* T2D: diagnosed by primary care physician\n* at risk of type 2 diabetes (obesity and physically inactive)\n* age: 21-65\n\nExclusion Criteria:\n\n* smoking\n* insulin use (other than once daily)\n* physically active (\\>30 mins aerobic exercise two days/week)\n* recent (\\>3 mo) changes in medication use or dose\n* uncontrolled type two diabetes (HbA1C \\>10%)\n* advanced retinopathy or neuropathy\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT02518334', 'acronym': 'WGC', 'briefTitle': 'Wine Consumption and Glycemic Control', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Wine Consumption and Glycemic Control', 'orgStudyIdInfo': {'id': 'Wine and GC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alcohol consumption', 'description': 'Alcohol consumption and wine consumption', 'interventionNames': ['Other: Alcohol consumption']}], 'interventions': [{'name': 'Alcohol consumption', 'type': 'OTHER', 'description': '28 grams (2 drinks) of ethanol will be consumed either in the form of wine or vodka.', 'armGroupLabels': ['Alcohol consumption']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65202', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'John P Thyfault, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri-Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}