Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-26 @ 1:06 AM
Study NCT ID:
NCT00295334
Status:
COMPLETED
Last Update Posted:
2025-06-24
First Post:
2006-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Moderate Alcohol Intake Among Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Israel']}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'irish@bgu.ac.il', 'phone': '+972086477443', 'title': 'Iris Shai', 'organization': 'Ben-Gurion University of the Negev'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Alcohol', 'description': 'All participants received individual dietary counseling by registered dietitians trained to work with type 2 diabetic patients. Each dietitian reinforced identical nutritional strategies to achieve glycemic control in both study groups but did not specifically try to promote weight loss. Reinforcement of dietary counseling for both groups was based on the American Diabetes Association recommendations for patients with type 2 diabetes, which include 45-60% calories from carbohydrates, up to 30% from fat (with restriction of saturated fat to \\<7% of total calories and minimization of trans fat), and 15-20% from protein.\n\nthe alcohol group was instructed to reduce carbohydrates by 100 kcal, but not at dinner, to decrease the likelihood of alcohol-induced hypoglycemia.\n\nPatients assigned to consume alcohol were instructed to start drinking gradually (over a 2-week period) 150 ml of wine (13% alcohol, 13 g) that we provided, using a standard measured glass, during dinner. The patients could choose either dry red (Merlot) or white (Sauvignon Blanc) wine; 75% chose red wine.', 'otherNumAtRisk': 75, 'otherNumAffected': 3, 'seriousNumAtRisk': 75, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'All participants received individual dietary counseling by registered dietitians trained to work with type 2 diabetic patients. Each dietitian reinforced identical nutritional strategies to achieve glycemic control in both study groups but did not specifically try to promote weight loss. Reinforcement of dietary counseling for both groups was based on the American Diabetes Association recommendations for patients with type 2 diabetes, which include 45-60% calories from carbohydrates, up to 30% from fat (with restriction of saturated fat to \\<7% of total calories and minimization of trans fat), and 15-20% from protein.\n\nParticipants randomly assigned to the control group were instructed to drink 150 ml of the nonalcoholic diet malt beer we provided, using the same standard measured glass, during dinner.', 'otherNumAtRisk': 34, 'otherNumAffected': 1, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'gastric pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alcohol', 'description': 'All participants received individual dietary counseling by registered dietitians trained to work with type 2 diabetic patients. Each dietitian reinforced identical nutritional strategies to achieve glycemic control in both study groups but did not specifically try to promote weight loss. Reinforcement of dietary counseling for both groups was based on the American Diabetes Association recommendations for patients with type 2 diabetes, which include 45-60% calories from carbohydrates, up to 30% from fat (with restriction of saturated fat to \\<7% of total calories and minimization of trans fat), and 15-20% from protein.\n\nthe alcohol group was instructed to reduce carbohydrates by 100 kcal, but not at dinner, to decrease the likelihood of alcohol-induced hypoglycemia.\n\nPatients assigned to consume alcohol were instructed to start drinking gradually (over a 2-week period) 150 ml of wine (13% alcohol, 13 g) that we provided, using a standard measured glass, during dinner. The patients could choose either dry red (Merlot) or white (Sauvignon Blanc) wine; 75% chose red wine.'}, {'id': 'OG001', 'title': 'Control', 'description': 'All participants received individual dietary counseling by registered dietitians trained to work with type 2 diabetic patients. Each dietitian reinforced identical nutritional strategies to achieve glycemic control in both study groups but did not specifically try to promote weight loss. Reinforcement of dietary counseling for both groups was based on the American Diabetes Association recommendations for patients with type 2 diabetes, which include 45-60% calories from carbohydrates, up to 30% from fat (with restriction of saturated fat to \\<7% of total calories and minimization of trans fat), and 15-20% from protein.\n\nParticipants randomly assigned to the control group were instructed to drink 150 ml of the nonalcoholic diet malt beer we provided, using the same standard measured glass, during dinner.'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.55', 'spread': '41.18', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '25.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Differance between 3 month time point minus baseline', 'description': 'A change from baseline to 3-month time points is reported', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alcohol', 'description': 'All participants received individual dietary counseling by registered dietitians trained to work with type 2 diabetic patients. Each dietitian reinforced identical nutritional strategies to achieve glycemic control in both study groups but did not specifically try to promote weight loss. Reinforcement of dietary counseling for both groups was based on the American Diabetes Association recommendations for patients with type 2 diabetes, which include 45-60% calories from carbohydrates, up to 30% from fat (with restriction of saturated fat to \\<7% of total calories and minimization of trans fat), and 15-20% from protein.\n\nthe alcohol group was instructed to reduce carbohydrates by 100 kcal, but not at dinner, to decrease the likelihood of alcohol-induced hypoglycemia.\n\nPatients assigned to consume alcohol were instructed to start drinking gradually (over a 2-week period) 150 ml of wine (13% alcohol, 13 g) that we provided, using a standard measured glass, during dinner. The patients could choose either dry red (Merlot) or white (Sauvignon Blanc) wine; 75% chose red wine.'}, {'id': 'OG001', 'title': 'Control', 'description': 'All participants received individual dietary counseling by registered dietitians trained to work with type 2 diabetic patients. Each dietitian reinforced identical nutritional strategies to achieve glycemic control in both study groups but did not specifically try to promote weight loss. Reinforcement of dietary counseling for both groups was based on the American Diabetes Association recommendations for patients with type 2 diabetes, which include 45-60% calories from carbohydrates, up to 30% from fat (with restriction of saturated fat to \\<7% of total calories and minimization of trans fat), and 15-20% from protein.\n\nParticipants randomly assigned to the control group were instructed to drink 150 ml of the nonalcoholic diet malt beer we provided, using the same standard measured glass, during dinner.'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Adherence at 3-months (end of intervention)', 'description': 'Count of participants that finished the 3-month intervention', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alcohol', 'description': 'All participants received individual dietary counseling by registered dietitians trained to work with type 2 diabetic patients. Each dietitian reinforced identical nutritional strategies to achieve glycemic control in both study groups but did not specifically try to promote weight loss. Reinforcement of dietary counseling for both groups was based on the American Diabetes Association recommendations for patients with type 2 diabetes, which include 45-60% calories from carbohydrates, up to 30% from fat (with restriction of saturated fat to \\<7% of total calories and minimization of trans fat), and 15-20% from protein.\n\nthe alcohol group was instructed to reduce carbohydrates by 100 kcal, but not at dinner, to decrease the likelihood of alcohol-induced hypoglycemia.\n\nPatients assigned to consume alcohol were instructed to start drinking gradually (over a 2-week period) 150 ml of wine (13% alcohol, 13 g) that we provided, using a standard measured glass, during dinner. The patients could choose either dry red (Merlot) or white (Sauvignon Blanc) wine; 75% chose red wine.'}, {'id': 'OG001', 'title': 'Control', 'description': 'All participants received individual dietary counseling by registered dietitians trained to work with type 2 diabetic patients. Each dietitian reinforced identical nutritional strategies to achieve glycemic control in both study groups but did not specifically try to promote weight loss. Reinforcement of dietary counseling for both groups was based on the American Diabetes Association recommendations for patients with type 2 diabetes, which include 45-60% calories from carbohydrates, up to 30% from fat (with restriction of saturated fat to \\<7% of total calories and minimization of trans fat), and 15-20% from protein.\n\nParticipants randomly assigned to the control group were instructed to drink 150 ml of the nonalcoholic diet malt beer we provided, using the same standard measured glass, during dinner.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.29', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '0.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Differance between 3 month time point minus baseline', 'description': 'A change from baseline to 3-month time points is reported', 'unitOfMeasure': '% of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'LDL, HDL, TG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alcohol', 'description': 'All participants received individual dietary counseling by registered dietitians trained to work with type 2 diabetic patients. Each dietitian reinforced identical nutritional strategies to achieve glycemic control in both study groups but did not specifically try to promote weight loss. Reinforcement of dietary counseling for both groups was based on the American Diabetes Association recommendations for patients with type 2 diabetes, which include 45-60% calories from carbohydrates, up to 30% from fat (with restriction of saturated fat to \\<7% of total calories and minimization of trans fat), and 15-20% from protein.\n\nthe alcohol group was instructed to reduce carbohydrates by 100 kcal, but not at dinner, to decrease the likelihood of alcohol-induced hypoglycemia.\n\nPatients assigned to consume alcohol were instructed to start drinking gradually (over a 2-week period) 150 ml of wine (13% alcohol, 13 g) that we provided, using a standard measured glass, during dinner. The patients could choose either dry red (Merlot) or white (Sauvignon Blanc) wine; 75% chose red wine.'}, {'id': 'OG001', 'title': 'Control', 'description': 'All participants received individual dietary counseling by registered dietitians trained to work with type 2 diabetic patients. Each dietitian reinforced identical nutritional strategies to achieve glycemic control in both study groups but did not specifically try to promote weight loss. Reinforcement of dietary counseling for both groups was based on the American Diabetes Association recommendations for patients with type 2 diabetes, which include 45-60% calories from carbohydrates, up to 30% from fat (with restriction of saturated fat to \\<7% of total calories and minimization of trans fat), and 15-20% from protein.\n\nParticipants randomly assigned to the control group were instructed to drink 150 ml of the nonalcoholic diet malt beer we provided, using the same standard measured glass, during dinner.'}], 'classes': [{'title': 'LDL', 'categories': [{'measurements': [{'value': '-11.53', 'spread': '29.22', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '24.03', 'groupId': 'OG001'}]}]}, {'title': 'HDL', 'categories': [{'measurements': [{'value': '-2.34', 'spread': '9.85', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '4.55', 'groupId': 'OG001'}]}]}, {'title': 'TG', 'categories': [{'measurements': [{'value': '23.05', 'spread': '81.10', 'groupId': 'OG000'}, {'value': '10.40', 'spread': '87.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'A change from baseline to 3-month time points is reported', 'description': 'Differance between 3 month time point minus baseline', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'All participants received individual dietary counseling by registered dietitians trained to work with type 2 diabetic patients. Each dietitian reinforced identical nutritional strategies to achieve glycemic control in both study groups but did not specifically try to promote weight loss. Reinforcement of dietary counseling for both groups was based on the American Diabetes Association recommendations for patients with type 2 diabetes, which include 45-60% calories from carbohydrates, up to 30% from fat (with restriction of saturated fat to \\<7% of total calories and minimization of trans fat), and 15-20% from protein.\n\nParticipants randomly assigned to the control group were instructed to drink 150 ml of the nonalcoholic diet malt beer we provided, using the same standard measured glass, during dinner.'}, {'id': 'FG001', 'title': 'Alcohol', 'description': 'All participants received individual dietary counseling by registered dietitians trained to work with type 2 diabetic patients. Each dietitian reinforced identical nutritional strategies to achieve glycemic control in both study groups but did not specifically try to promote weight loss. Reinforcement of dietary counseling for both groups was based on the American Diabetes Association recommendations for patients with type 2 diabetes, which include 45-60% calories from carbohydrates, up to 30% from fat (with restriction of saturated fat to \\<7% of total calories and minimization of trans fat), and 15-20% from protein.\n\nthe alcohol group was instructed to reduce carbohydrates by 100 kcal, but not at dinner, to decrease the likelihood of alcohol-induced hypoglycemia.\n\nPatients assigned to consume alcohol were instructed to start drinking gradually (over a 2-week period) 150 ml of wine (13% alcohol, 13 g) that we provided, using a standard measured glass, during dinner. The patients could choose either dry red (Merlot) or white (Sauvignon Blanc) wine.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'Chosen Wine (Red, n)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Alcohol', 'description': 'All participants received individual dietary counseling by registered dietitians trained to work with type 2 diabetic patients. Each dietitian reinforced identical nutritional strategies to achieve glycemic control in both study groups but did not specifically try to promote weight loss. Reinforcement of dietary counseling for both groups was based on the American Diabetes Association recommendations for patients with type 2 diabetes, which include 45-60% calories from carbohydrates, up to 30% from fat (with restriction of saturated fat to \\<7% of total calories and minimization of trans fat), and 15-20% from protein.\n\nthe alcohol group was instructed to reduce carbohydrates by 100 kcal, but not at dinner, to decrease the likelihood of alcohol-induced hypoglycemia.\n\nPatients assigned to consume alcohol were instructed to start drinking gradually (over a 2-week period) 150 ml of wine (13% alcohol, 13 g) that we provided, using a standard measured glass, during dinner. The patients could choose either dry red (Merlot) or white (Sauvignon Blanc) wine; 75% chose red wine.'}, {'id': 'BG001', 'title': 'Control', 'description': 'All participants received individual dietary counseling by registered dietitians trained to work with type 2 diabetic patients. Each dietitian reinforced identical nutritional strategies to achieve glycemic control in both study groups but did not specifically try to promote weight loss. Reinforcement of dietary counseling for both groups was based on the American Diabetes Association recommendations for patients with type 2 diabetes, which include 45-60% calories from carbohydrates, up to 30% from fat (with restriction of saturated fat to \\<7% of total calories and minimization of trans fat), and 15-20% from protein.\n\nParticipants randomly assigned to the control group were instructed to drink 150 ml of the nonalcoholic diet malt beer we provided, using the same standard measured glass, during dinner.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.1', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '61.1', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '61.1', 'spread': '6.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Israel', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2006-02-21', 'resultsFirstSubmitDate': '2024-05-04', 'studyFirstSubmitQcDate': '2006-02-21', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-05', 'studyFirstPostDateStruct': {'date': '2006-02-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose', 'timeFrame': 'Differance between 3 month time point minus baseline', 'description': 'A change from baseline to 3-month time points is reported'}, {'measure': 'Adherence', 'timeFrame': 'Adherence at 3-months (end of intervention)', 'description': 'Count of participants that finished the 3-month intervention'}, {'measure': 'HbA1c', 'timeFrame': 'Differance between 3 month time point minus baseline', 'description': 'A change from baseline to 3-month time points is reported'}], 'secondaryOutcomes': [{'measure': 'LDL, HDL, TG', 'timeFrame': 'A change from baseline to 3-month time points is reported', 'description': 'Differance between 3 month time point minus baseline'}]}, 'conditionsModule': {'keywords': ['adherence', 'glycemic control'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '17848609', 'type': 'DERIVED', 'citation': 'Shai I, Wainstein J, Harman-Boehm I, Raz I, Fraser D, Rudich A, Stampfer MJ. Glycemic effects of moderate alcohol intake among patients with type 2 diabetes: a multicenter, randomized, clinical intervention trial. Diabetes Care. 2007 Dec;30(12):3011-6. doi: 10.2337/dc07-1103. Epub 2007 Sep 11.'}], 'seeAlsoLinks': [{'url': 'http://pubmed.ncbi.nlm.nih.gov/17848609/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Our specific aim is to explore the effect of moderate alcohol intake on parameters of glycemic index and lipid profile among patients with type 2 diabetes.', 'detailedDescription': "Successful long-term control of hyperglycemia decreases the risk for diabetic complications . Although a family history of diabetes is an established risk factor for type 2 diabetes, lifestyle factors also play an important role in its cause . However, physicians are poorly informed about how their patients' alcohol use affects risk for or management of diabetes. Moderate alcohol consumption has been associated with lower risk of both cardiovascular disease and type 2 diabetes, and is also linked to lower cardiovascular risk among type 2 diabetics. Potential mechanisms have focused primarily on lipid metabolism, coagulation, fibrinolysis, and insulin sensitivity. A recent systematic review of the literature to assess the effect of alcohol consumption on risk for and management and complications of diabetes mellitus suggests that moderate alcohol consumption is associated with a decreased risk for diabetes, whereas heavy alcohol consumption may be associated with an increased risk. Our aim is to assess the effect of moderate alcohol intake on glycemic control and cardiovascular disease mediators among patients with type 2 diabetes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age between 40-75 yrs.\n2. Alcohol abstainers (less than or equal to 1 drink/week)\n3. Established diagnosis of type 2 diabetes.\n4. Clinically stable, with no stroke or MI within the last 3 months and no major surgery within the last 3 months.\n\nExclusion Criteria:\n\n1. Taking Insulin \\>2 injections /day, or with insulin pump.\n2. TGs\\>500 mg/dL.\n3. HbA1c \\>10%\n4. Serum creatinine \\> 2 mg/dl\n5. Liver dysfunction (above 2 fold level of ALT and/or AST enzymes)\n\n5\\. Evidence of severe diabetes complications (such as proliferative retinopathy or renal disease).\n\n6\\. Patients with autonomic neuropathy manifested as postural hypertension and/or hypoglycemia unawareness. 7. Using drugs that might significantly interact with moderate alcohol. List of drugs will be obtained from pharmacology expert. 8. Presence of active cancer, receiving or had received chemotherapy in last 3 years.\n\n9\\. Suffering a major illness that might probably require hospitalization (upon physician's evaluation).\n\n10\\. Clinically assessed as having high potential of addictive behavior as judged by a validated clinical assessment and/or personal or family history of addiction, alcoholism or alcohol abuse.\n\n11\\. Severe symptoms during run-in as assessed by the physician. 12. Pregnant or lactating women. 13. Participation in another trial in which active intervention is being received.\n\n\\-"}, 'identificationModule': {'nctId': 'NCT00295334', 'briefTitle': 'Moderate Alcohol Intake Among Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'The S. Daniel Abraham International Center for Health and Nutrition'}, 'orgStudyIdInfo': {'id': '250505'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mediterranean diet + red wine', 'interventionNames': ['Drug: alcohol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mediterranean diet + white wine', 'interventionNames': ['Drug: alcohol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Mediterranean diet+ mineral water', 'interventionNames': ['Drug: alcohol']}], 'interventions': [{'name': 'alcohol', 'type': 'DRUG', 'armGroupLabels': ['Mediterranean diet + red wine', 'Mediterranean diet + white wine', 'Mediterranean diet+ mineral water']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Iris Shai, RD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ben-Gurion University of the Negev'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iris Shai', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Israeli Diabetes Research Group', 'class': 'UNKNOWN'}, {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, {'name': 'Soroka University Medical Center', 'class': 'OTHER'}, {'name': 'Julio Vainstein, Wolfson Medical Center, Holon, Israel', 'class': 'UNKNOWN'}, {'name': 'Tishbi Wines, Israel and Admiral Wine Imports, US', 'class': 'UNKNOWN'}, {'name': 'Harvard University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Iris Shai', 'investigatorAffiliation': 'The S. Daniel Abraham International Center for Health and Nutrition'}}}}