{"protocolSection":{"identificationModule":{"nctId":"NCT03010683","orgStudyIdInfo":{"id":"GLP1-DM-ATTIKON"},"organization":{"fullName":"University of Athens","class":"OTHER"},"briefTitle":"Effects of Agonists of Glucagon Like Peptide - 1 Receptors (GLP-1R) on Arterial Stiffness, Endothelial Glycocalyx and Coronary Flow Reserve in Patients With Coronary Artery Disease and Patients With Diabetes Mellitus","officialTitle":"Effects of Agonists of Glucagon Like Peptide - 1 Receptors (GLP-1R) on Arterial Stiffness, Endothelial Glycocalyx and Coronary Flow Reserve in Patients With Coronary Artery Disease and Patients With Diabetes Mellitus"},"statusModule":{"statusVerifiedDate":"2021-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2015-11"},"primaryCompletionDateStruct":{"date":"2017-06","type":"ACTUAL"},"completionDateStruct":{"date":"2017-12","type":"ACTUAL"},"studyFirstSubmitDate":"2016-12-22","studyFirstSubmitQcDate":"2017-01-03","studyFirstPostDateStruct":{"date":"2017-01-05","type":"ESTIMATED"},"resultsFirstSubmitDate":"2020-11-03","resultsFirstSubmitQcDate":"2021-03-03","resultsFirstPostDateStruct":{"date":"2021-03-05","type":"ACTUAL"},"lastUpdateSubmitDate":"2021-03-03","lastUpdatePostDateStruct":{"date":"2021-03-05","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Ignatios Ikonomidis","investigatorTitle":"Associate Professor in Cardiology","investigatorAffiliation":"University of Athens"},"leadSponsor":{"name":"University of Athens","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"Arterial stiffness is associated with increased risk for cardiovascular disease. Moreover, the integrity of endothelial glycocalyx plays a vital role in vascular permeability, inflammation and elasticity. Agonists of Glucagon like peptide - 1 receptors (GLP-1R) used in the treatment of type 2 diabetes mellitus (T2DM). This category includes exenatide and liraglutide. These drugs lower glucose levels by inhibiting the secretion of glucagon, promoting the release of insulin in response to hyperglycemia, slowing gastric emptying, and augmenting satiety. Clinical studies have shown that GLP-1R agonists have beneficial effects on cardiovascular function in both diabetic patients and healthy subjects. The purpose of this study is to investigate in patients with T2DM without coronary artery disease (CAD), patients with T2DM and CAD and obese patients with abnormal oral glucose tolerance test (OGTT), changes in arterial stiffness, endothelial glycocalyx thickness and coronary reserve flow (CFR) after treatment with metformin or agonist GLP-1R.","detailedDescription":"The investigators will study three groups matched for age and sex: 30 patients with type 2 diabetes mellitus (T2DM) without coronary artery disease (CAD), 30 patients with T2DM and CAD and 30 obese patients (BMI \\>30 Kg/m²) with abnormal oral glucose tolerance test (OGTT). It will be a randomized study with metformin or GLP-1R agonist treatment for 1 year. All subjects will receive for 1 year: (a) GLP-1R agonist or (b) metformin. At 0, 3, 6 and 12 months, where 0 is the starting point of treatment, blood samples will be collected.\n\nAt 0, 3, 6 and 12 months the investigators will measure:\n\n1. Carotid-femoral pulse wave velocity (PWV, m/sec) using tonometry by Complior (SP ALAM) and augmentation index (AI, %) by the method of arteriography (Arteriograph, TensioMed)\n2. Perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels (ranged from 5-25 micrometers) using Sideview Darkfield imaging (Microscan, Glycocheck). Increased PBR is considered an accurate non invasive index of reduced endothelial glucocalyx thickness.\n3. Coronary flow reserve (CFR) in the left anterior descending artery after infusion of adenosine using Doppler echocardiography.\n4. Determination of the following parameters in blood: glucose, insulin, free fatty acids, triglycerides, glycerol, C reactive protein (CRP), transforming growth factor-b (TGF-b), Lipoprotein-Associated Phospholipase A2 (LP-LPA2), tumor necrosis factor-a (TNF-a), interleukins 6 and 10 (IL6 and IL10), propeptide of type I procollagen (PIP), propeptide of procollagen type III (PIIINP), matrix metallopeptidases 9 and 2 (MMP), macrophage-colony stimulating factor (MCSF), growth differentiation factor-15 (GDF-15), N-terminal pro b-type natriuretic peptide (NT-proBNP) and galectin-3."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus","Coronary Artery Disease"],"keywords":["Arterial stiffness","Endothelial glycocalyx","Coronary flow reserve"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"SINGLE","whoMasked":["INVESTIGATOR"]}},"enrollmentInfo":{"count":60,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"liraglutide","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: Liraglutide"]},{"label":"Metformin","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: Metformin"]}],"interventions":[{"type":"DRUG","name":"Liraglutide","description":"Stimulation of Glucagon like peptide-1 receptor by liraglutide (Victoza) 1.8mg once daily as a subcutaneous injection","armGroupLabels":["liraglutide"],"otherNames":["Victoza (liraglutide)"]},{"type":"DRUG","name":"Metformin","description":"Antidiabetic drug-biguanide class (Glucophage) 1000mg twice daily per os","armGroupLabels":["Metformin"],"otherNames":["Glucophage (Metformin)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Differences in Pulse Wave Velocity at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.","description":"Differences in carotid-femoral pulse wave velocity (PWV, m/sec) using tonometry at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R.","timeFrame":"Baseline, 3 months, 6 months and 12 months"},{"measure":"Differences in Augmentation Index at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.","description":"Differences in augmentation index (AI, %) using oscillometry at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R.","timeFrame":"Baseline, 3 months, 6 months, and 12 months."},{"measure":"Differences in Coronary Flow Reserve at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.","description":"Differences in coronary flow reserve (CFR) using Doppler echocardiography at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R.","timeFrame":"Baseline, 3 months, 6 months, and 12 months."},{"measure":"Differences in Endothelial Glycocalyx Thickness at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.","description":"Differences in endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R. High PBR values represent reduced glycocalyx thickness.","timeFrame":"Baseline, 3 months, 6 months, and 12 months."}],"secondaryOutcomes":[{"measure":"Endothelial Glycocalyx and Pulse Wave Velocity.","description":"Association of endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels with pulse wave velocity (PWV, m/sec) at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R.","timeFrame":"Baseline, 3 months, 6 months, and 12 months."},{"measure":"Endothelial Glycocalyx and Coronary Flow Reserve.","description":"Association of endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels with coronary flow reserve (CFR) using Doppler echocardiography at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R.","timeFrame":"Baseline, 3 months, 6 months, and 12 months."}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Patients with type 2 diabetes mellitus (T2DM) without coronary artery disease (CAD)\n* Patients with T2DM and CAD.\n* Obese patients (BMI \\>30 Kg/m²) with abnormal oral glucose tolerance test (OGTT)\n\nExclusion Criteria:\n\n* valvular heart disease\n* congestive heart failure\n* peripheral vascular disease\n* liver or kidney failure\n* history of alcohol or drug abuse","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Ignatios Ikonomidis, MD","affiliation":"2nd Cardiology Department, University of Athens, Greece","role":"PRINCIPAL_INVESTIGATOR"},{"name":"George Pavlidis, MD","affiliation":"2nd Cardiology Department, University of Athens, Greece","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Vaia Lambadiari, MD","affiliation":"2nd Department of Internal Medicine, University of Athens, Greece","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Fotini Kousathana, MD","affiliation":"2nd Department of Internal Medicine, University of Athens, Greece","role":"PRINCIPAL_INVESTIGATOR"},{"name":"George Dimitriadis, MD","affiliation":"2nd Department of Internal Medicine, University of Athens, Greece","role":"PRINCIPAL_INVESTIGATOR"},{"name":"John Lekakis, MD","affiliation":"2nd Cardiology Department, University of Athens, Greece","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"''Attikon'' University General Hospital","city":"Athens","state":"Attica","zip":"12462","country":"Greece","geoPoint":{"lat":37.98376,"lon":23.72784}}]},"referencesModule":{"references":[{"pmid":"32501595","type":"DERIVED","citation":"Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2."},{"pmid":"29310645","type":"DERIVED","citation":"Lambadiari V, Pavlidis G, Kousathana F, Varoudi M, Vlastos D, Maratou E, Georgiou D, Andreadou I, Parissis J, Triantafyllidi H, Lekakis J, Iliodromitis E, Dimitriadis G, Ikonomidis I. Effects of 6-month treatment with the glucagon like peptide-1 analogue liraglutide on arterial stiffness, left ventricular myocardial deformation and oxidative stress in subjects with newly diagnosed type 2 diabetes. Cardiovasc Diabetol. 2018 Jan 8;17(1):8. doi: 10.1186/s12933-017-0646-z."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Liraglutide","description":"Stimulation of glucagon like peptide-1 receptor by liraglutide (Victoza) 1.8 mg once daily as a subcutaneous injection"},{"id":"FG001","title":"Metformin","description":"Antidiabetic drug - biguanide class (Glucophage) 1000 mg twice daily per os"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"30"},{"groupId":"FG001","numSubjects":"30"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"30"},{"groupId":"FG001","numSubjects":"30"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Liraglutide","description":"Stimulation of glucagon like peptide-1 receptor by liraglutide (Victoza) 1.8 mg once daily as a subcutaneous injection"},{"id":"BG001","title":"Metformin","description":"Antidiabetic drug - biguanide class (Glucophage) 1000 mg twice daily per os"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"30"},{"groupId":"BG002","value":"60"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"6"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"40"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"14"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"20"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"40"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Greeks","categories":[{"measurements":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"30"},{"groupId":"BG002","value":"60"}]}]}]},{"title":"Pulse Wave Velocity","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"m/s","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"11.8","spread":"2.5"},{"groupId":"BG001","value":"11.2","spread":"3"},{"groupId":"BG002","value":"11.5","spread":"2.8"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Differences in Pulse Wave Velocity at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.","description":"Differences in carotid-femoral pulse wave velocity (PWV, m/sec) using tonometry at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"m/s","timeFrame":"Baseline, 3 months, 6 months and 12 months","groups":[{"id":"OG000","title":"Liraglutide","description":"Stimulation of glucagon like peptide-1 receptor by liraglutide (Victoza) 1.8 mg once daily as a subcutaneous injection"},{"id":"OG001","title":"Metformin","description":"Antidiabetic drug - biguanide class (Glucophage) 1000 mg twice daily per os"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"30"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"11.8","spread":"2.5"},{"groupId":"OG001","value":"11.2","spread":"3"}]}]},{"title":"3 months","categories":[{"measurements":[{"groupId":"OG000","value":"11.6","spread":"2.8"},{"groupId":"OG001","value":"11.5","spread":"2.7"}]}]},{"title":"6 months","categories":[{"measurements":[{"groupId":"OG000","value":"10.3","spread":"3.3"},{"groupId":"OG001","value":"11","spread":"3"}]}]},{"title":"12 months","categories":[{"measurements":[{"groupId":"OG000","value":"10.5","spread":"1.9"},{"groupId":"OG001","value":"10.8","spread":"2"}]}]}]},{"type":"PRIMARY","title":"Differences in Augmentation Index at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.","description":"Differences in augmentation index (AI, %) using oscillometry at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"percentage of the central pulse pressure","timeFrame":"Baseline, 3 months, 6 months, and 12 months.","groups":[{"id":"OG000","title":"Liraglutide","description":"Stimulation of glucagon like peptide-1 receptor by liraglutide (Victoza) 1.8 mg once daily as a subcutaneous injection"},{"id":"OG001","title":"Metformin","description":"Antidiabetic drug - biguanide class (Glucophage) 1000 mg twice daily per os"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"30"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"18","lowerLimit":"-1","upperLimit":"31"},{"groupId":"OG001","value":"14","lowerLimit":"-9","upperLimit":"24"}]}]},{"title":"3 months","categories":[{"measurements":[{"groupId":"OG000","value":"15.8","lowerLimit":"-2","upperLimit":"29"},{"groupId":"OG001","value":"13.6","lowerLimit":"-6","upperLimit":"25"}]}]},{"title":"6 months","categories":[{"measurements":[{"groupId":"OG000","value":"13","lowerLimit":"-2","upperLimit":"31"},{"groupId":"OG001","value":"15","lowerLimit":"-8","upperLimit":"24"}]}]},{"title":"12 months","categories":[{"measurements":[{"groupId":"OG000","value":"13.9","lowerLimit":"-1","upperLimit":"32"},{"groupId":"OG001","value":"15.3","lowerLimit":"-6","upperLimit":"24"}]}]}]},{"type":"PRIMARY","title":"Differences in Coronary Flow Reserve at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.","description":"Differences in coronary flow reserve (CFR) using Doppler echocardiography at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R.","populationDescription":"The investigators did not measure coronary flow reserve (CFR).","reportingStatus":"POSTED","timeFrame":"Baseline, 3 months, 6 months, and 12 months.","groups":[{"id":"OG000","title":"Liraglutide","description":"Stimulation of glucagon like peptide-1 receptor by liraglutide (Victoza) 1.8 mg once daily as a subcutaneous injection"},{"id":"OG001","title":"Metformin","description":"Antidiabetic drug - biguanide class (Glucophage) 1000 mg twice daily per os"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"PRIMARY","title":"Differences in Endothelial Glycocalyx Thickness at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.","description":"Differences in endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R. High PBR values represent reduced glycocalyx thickness.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"micrometers","timeFrame":"Baseline, 3 months, 6 months, and 12 months.","groups":[{"id":"OG000","title":"Liraglutide","description":"Stimulation of glucagon like peptide-1 receptor by liraglutide (Victoza) 1.8 mg once daily as a subcutaneous injection"},{"id":"OG001","title":"Metformin","description":"Antidiabetic drug - biguanide class (Glucophage) 1000 mg twice daily per os"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"30"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"2.1","spread":"0.29"},{"groupId":"OG001","value":"2.13","spread":"0.3"}]}]},{"title":"3 months","categories":[{"measurements":[{"groupId":"OG000","value":"2.07","spread":"0.3"},{"groupId":"OG001","value":"2.15","spread":"0.3"}]}]},{"title":"6 months","categories":[{"measurements":[{"groupId":"OG000","value":"2.5","spread":"0.2"},{"groupId":"OG001","value":"2.13","spread":"0.3"}]}]},{"title":"12 months","categories":[{"measurements":[{"groupId":"OG000","value":"2.04","spread":"0.2"},{"groupId":"OG001","value":"2.10","spread":"0.3"}]}]}]},{"type":"SECONDARY","title":"Endothelial Glycocalyx and Pulse Wave Velocity.","description":"Association of endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels with pulse wave velocity (PWV, m/sec) at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Pearson correlation coefficient (r)","timeFrame":"Baseline, 3 months, 6 months, and 12 months.","groups":[{"id":"OG000","title":"Liraglutide","description":"Stimulation of glucagon like peptide-1 receptor by liraglutide (Victoza) 1.8 mg once daily as a subcutaneous injection"},{"id":"OG001","title":"Metformin","description":"Antidiabetic drug - biguanide class (Glucophage) 1000 mg twice daily per os"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"30"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"0.39"},{"groupId":"OG001","value":"0.35"}]}]},{"title":"3 months","categories":[{"measurements":[{"groupId":"OG000","value":"0.36"},{"groupId":"OG001","value":"0.32"}]}]},{"title":"6 months","categories":[{"measurements":[{"groupId":"OG000","value":"0.32"},{"groupId":"OG001","value":"0.29"}]}]},{"title":"12 months","categories":[{"measurements":[{"groupId":"OG000","value":"0.44"},{"groupId":"OG001","value":"0.37"}]}]}]},{"type":"SECONDARY","title":"Endothelial Glycocalyx and Coronary Flow Reserve.","description":"Association of endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels with coronary flow reserve (CFR) using Doppler echocardiography at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R.","populationDescription":"The investigators did not estimate the association between endothelial glycocalyx thickness and coronary flow reserve (CFR) because they did not measure the CFR.","reportingStatus":"POSTED","timeFrame":"Baseline, 3 months, 6 months, and 12 months.","groups":[{"id":"OG000","title":"Liraglutide","description":"Stimulation of glucagon like peptide-1 receptor by liraglutide (Victoza) 1.8 mg once daily as a subcutaneous injection"},{"id":"OG001","title":"Metformin","description":"Antidiabetic drug - biguanide class (Glucophage) 1000 mg twice daily per os"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"12 months","eventGroups":[{"id":"EG000","title":"Liraglutide","description":"Stimulation of glucagon like peptide-1 receptor by liraglutide (Victoza) 1.8 mg once daily as a subcutaneous injection","deathsNumAffected":0,"deathsNumAtRisk":30,"seriousNumAffected":0,"seriousNumAtRisk":30,"otherNumAffected":0,"otherNumAtRisk":30},{"id":"EG001","title":"Metformin","description":"Antidiabetic drug - biguanide class (Glucophage) 1000 mg twice daily per os","deathsNumAffected":0,"deathsNumAtRisk":30,"seriousNumAffected":0,"seriousNumAtRisk":30,"otherNumAffected":0,"otherNumAtRisk":30}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"Οur study has a modest number of subjects. Additional large scale studies are needed to expand our results."},"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Dr Ignatios Ikonomidis","organization":"2nd Cardiology Department, National and Kapodistrian University of Athens, Attikon Hospital","email":"ignoik@gmail.com","phone":"+30 6944805732"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2016-12-22","uploadDate":"2021-01-24T16:24","filename":"Prot_SAP_000.pdf","size":51836}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D003924","term":"Diabetes Mellitus, Type 2"},{"id":"D003324","term":"Coronary Artery Disease"}],"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"},{"id":"D003327","term":"Coronary Disease"},{"id":"D017202","term":"Myocardial Ischemia"},{"id":"D006331","term":"Heart Diseases"},{"id":"D002318","term":"Cardiovascular Diseases"},{"id":"D001161","term":"Arteriosclerosis"},{"id":"D001157","term":"Arterial Occlusive Diseases"},{"id":"D014652","term":"Vascular Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D000069450","term":"Liraglutide"},{"id":"D008687","term":"Metformin"}],"ancestors":[{"id":"D052216","term":"Glucagon-Like Peptide 1"},{"id":"D004763","term":"Glucagon-Like Peptides"},{"id":"D052336","term":"Proglucagon"},{"id":"D005768","term":"Gastrointestinal Hormones"},{"id":"D006728","term":"Hormones"},{"id":"D006730","term":"Hormones, Hormone Substitutes, and Hormone Antagonists"},{"id":"D001645","term":"Biguanides"},{"id":"D006146","term":"Guanidines"},{"id":"D000578","term":"Amidines"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}