Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-31 @ 2:28 AM
Study NCT ID:
NCT00784433
Status:
COMPLETED
Last Update Posted:
2019-07-15
First Post:
2008-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The CArdiovasCulAr Diabetes & Ethanol (CASCADE) Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D011236', 'term': 'Prediabetic State'}], 'ancestors': [{'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-11', 'studyFirstSubmitDate': '2008-11-03', 'studyFirstSubmitQcDate': '2008-11-03', 'lastUpdatePostDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic control', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'CVD status', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['alcohol diabetes CVD'], 'conditions': ['Diabetes', 'Prediabetes']}, 'referencesModule': {'references': [{'pmid': '27692023', 'type': 'DERIVED', 'citation': 'Golan R, Shelef I, Shemesh E, Henkin Y, Schwarzfuchs D, Gepner Y, Harman-Boehm I, Witkow S, Friger M, Chassidim Y, Liberty IF, Sarusi B, Serfaty D, Bril N, Rein M, Cohen N, Ben-Avraham S, Ceglarek U, Stumvoll M, Bluher M, Thiery J, Stampfer MJ, Rudich A, Shai I. Effects of initiating moderate wine intake on abdominal adipose tissue in adults with type 2 diabetes: a 2-year randomized controlled trial. Public Health Nutr. 2017 Feb;20(3):549-555. doi: 10.1017/S1368980016002597. Epub 2016 Oct 3.'}, {'pmid': '26458258', 'type': 'DERIVED', 'citation': 'Gepner Y, Golan R, Harman-Boehm I, Henkin Y, Schwarzfuchs D, Shelef I, Durst R, Kovsan J, Bolotin A, Leitersdorf E, Shpitzen S, Balag S, Shemesh E, Witkow S, Tangi-Rosental O, Chassidim Y, Liberty IF, Sarusi B, Ben-Avraham S, Helander A, Ceglarek U, Stumvoll M, Bluher M, Thiery J, Rudich A, Stampfer MJ, Shai I. Effects of Initiating Moderate Alcohol Intake on Cardiometabolic Risk in Adults With Type 2 Diabetes: A 2-Year Randomized, Controlled Trial. Ann Intern Med. 2015 Oct 20;163(8):569-79. doi: 10.7326/M14-1650. Epub 2015 Oct 13.'}, {'pmid': '26232779', 'type': 'DERIVED', 'citation': 'Gepner Y, Henkin Y, Schwarzfuchs D, Golan R, Durst R, Shelef I, Harman-Boehm I, Spitzen S, Witkow S, Novack L, Friger M, Tangi-Rosental O, Sefarty D, Bril N, Rein M, Cohen N, Chassidim Y, Sarusi B, Wolak T, Stampfer MJ, Rudich A, Shai I. Differential Effect of Initiating Moderate Red Wine Consumption on 24-h Blood Pressure by Alcohol Dehydrogenase Genotypes: Randomized Trial in Type 2 Diabetes. Am J Hypertens. 2016 Apr;29(4):476-83. doi: 10.1093/ajh/hpv126. Epub 2015 Aug 1.'}]}, 'descriptionModule': {'briefSummary': 'Moderate alcohol may be beneficial for diabetics'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Established diagnosis of type 2 diabetes\n* Male or female alcohol abstainers (not more than 1 drink/week)\n* Age between 40-75 yrs\n* Clinically stable, with no history of stroke or myocardial infarction or major surgery within the previous 3 months\n\nExclusion Criteria:\n\n* The use of RI or short-acting analog insulin/ pump therapy. Patients on 1-2 injections per day of NPH or long-acting analogs will be eligible for inclusion\n* Triglycerides \\> 500 mg/dL\n* HbA1c\\<7 or \\> 10%\n* Serum creatinine \\> 2 mg/dl\n* Liver dysfunction (greater than 2-fold elevation of ALT or and 3-fold elevation of AST)\n* Evidence of severe diabetes complications (such as proliferative retinopathy or overt nephropathy)\n* Autonomic neuropathy manifested as postural hypotension or hypoglycemia unawareness\n* Patients with chronic hepatitis (C,B)\n* Use of drugs that might significantly interact with alcohol such as sedatives, antihistamines, and anti-coagulants\n* Presence of active cancer, or chemotherapy within the past 3 years\n* Major illness that may require hospitalization\n* A high potential of addictive behavior based on physician's assessment or personal or family history of addiction, alcoholism, or alcohol abuse\n* Pregnant or lactating woman\n* Participation in another trial with active intervention"}, 'identificationModule': {'nctId': 'NCT00784433', 'acronym': 'CASCADE', 'briefTitle': 'The CArdiovasCulAr Diabetes & Ethanol (CASCADE) Trial', 'organization': {'class': 'OTHER', 'fullName': 'Ben-Gurion University of the Negev'}, 'officialTitle': 'Cardiovascular and Metabolic Effects of Moderate Alcohol Consumption in Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'SOR478108CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'alcohol 1', 'interventionNames': ['Dietary Supplement: alcohol']}, {'type': 'EXPERIMENTAL', 'label': 'alcohol 2', 'interventionNames': ['Dietary Supplement: alcohol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'interventionNames': ['Dietary Supplement: alcohol']}], 'interventions': [{'name': 'alcohol', 'type': 'DIETARY_SUPPLEMENT', 'description': '150 cc', 'armGroupLabels': ['alcohol 1', 'alcohol 2', 'control']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ben-Gurion University of the Negev', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Iris Shai', 'investigatorFullName': 'Iris Shai', 'investigatorAffiliation': 'Ben-Gurion University of the Negev'}}}}