{"protocolSection":{"identificationModule":{"nctId":"NCT04881110","orgStudyIdInfo":{"id":"2_0401_2021"},"organization":{"fullName":"University of Campania Luigi Vanvitelli","class":"OTHER"},"briefTitle":"Liraglutide and Peripheral Artery Disease","officialTitle":"Effects of the Glucagon Like-peptide 1 (GLP-1) Receptor Agonist Liraglutide on Lower Limb Perfusion in People With Type 2 Diabetes and Peripheral Artery Disease: a Randomized Controlled Trial","acronym":"STARDUST"},"statusModule":{"statusVerifiedDate":"2025-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-02-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-12-31","type":"ACTUAL"},"completionDateStruct":{"date":"2022-12-31","type":"ACTUAL"},"studyFirstSubmitDate":"2021-05-06","studyFirstSubmitQcDate":"2021-05-10","studyFirstPostDateStruct":{"date":"2021-05-11","type":"ACTUAL"},"resultsFirstSubmitDate":"2023-12-13","resultsFirstSubmitQcDate":"2025-02-12","resultsFirstPostDateStruct":{"date":"2025-03-03","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-02-12","lastUpdatePostDateStruct":{"date":"2025-03-03","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Katherine Esposito","investigatorTitle":"Professor of Endocrinology and Metabolic Diseases, Head of Unit of Diabetes","investigatorAffiliation":"University of Campania Luigi Vanvitelli"},"leadSponsor":{"name":"University of Campania Luigi Vanvitelli","class":"OTHER"}},"oversightModule":{"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"STARDUST is an open-label, two-arm randomized controlled trial, aimed at evaluating the effects of liraglutide on peripheral perfusion, as compared with the aggressive treatment of cardio-metabolic risk factors, in people with type 2 diabetes and peripheral artery disease. The potential benefits for participants in the study include the possibility of improving peripheral perfusion with drugs that have been evaluated as effective in controlling diabetes and safe and protective for cardiovascular health.\n\nThe primary outcome of the study is the change of peripheral transcutaneous oxygen tension between groups at three and six months. Participants in the study will be followed for 6 months in order to evaluate the effects of liraglutide and the change of other secondary outcomes.","detailedDescription":"An 18-month extension of the follow-up will be performed for all the study population, according to guidelines and good clinical practice. The follow-up will include the glyco-metabolic parameters and the main cardiovascular risk factors, including TcPO2 assessment.\n\nData from this extended observation will be collected for additional analyses (mostly regarding the durability of the effects). Individuals who will be lost during follow-up and/or discontinue or modify the glucose-lowering treatment will be excluded from the analyses."},"conditionsModule":{"conditions":["Type 2 Diabetes","Peripheral Arterial Disease"],"keywords":["Type 2 diabetes","Liraglutide","Transcutaneous Oxygen Tension","Peripheral arterial disease","Inflammation","Angiogenesis","Endothelial Dysfunction","Diabetic microvascular complications"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"SINGLE","whoMasked":["OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":60,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Liraglutide group","type":"EXPERIMENTAL","description":"Patients in this arm will receive liraglutide, according to the current clinical practice.","interventionNames":["Drug: Liraglutide"]},{"label":"Control group","type":"OTHER","description":"Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.","interventionNames":["Other: Control"]}],"interventions":[{"type":"DRUG","name":"Liraglutide","description":"Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one.","armGroupLabels":["Liraglutide group"],"otherNames":["Intervention group"]},{"type":"OTHER","name":"Control","description":"Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice.","armGroupLabels":["Control group"],"otherNames":["Control group"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Peripheral Transcutaneous Oxygen Pressure","description":"Transcutaneous oxygen pressure (mmHg) on the lowest value recorded on anterior or posterior tibial artery after 6 months","timeFrame":"6 months"}],"secondaryOutcomes":[{"measure":"HbA1c Glucose Control","description":"HbA1c values after 6 months","timeFrame":"6 months"},{"measure":"Glucose Control","description":"fasting glucose differences between groups","timeFrame":"6 months"},{"measure":"Weight Change","description":"Weight value at 6 months minus value at baseline","timeFrame":"6 months"},{"measure":"BMI Change","description":"BMI value at 6 months minus value at baseline","timeFrame":"6 months"},{"measure":"Waist Circumference Change","description":"Waist circumference value at 6 months minus value at baseline","timeFrame":"6 months"},{"measure":"Systolic Blood Pressure Change","description":"systolic blood pressure value at 6 months minus value at baseline","timeFrame":"6 months"},{"measure":"Lipid Profile","description":"total cholesterol after 6 months","timeFrame":"6 months"},{"measure":"C-reactive Protein (CRP) Change","description":"CRP value at 6 months minus value at baseline","timeFrame":"6 months"},{"measure":"Renal Function","description":"creatinine levels after 6 months","timeFrame":"6 months"},{"measure":"Estimated Glomerular Filtration Rate","description":"estimated glomerular filtration rate after 6 months","timeFrame":"6 months"},{"measure":"Angiogenesis","description":"vascular endothelial growth factor (VEGF) after 6 months","timeFrame":"6 months"},{"measure":"Ankle-brachial Index (ABI) Change","description":"ABI value after 6 months minus value at baseline ABI evaluation was obtained dividing the leg systolic pressure by the arm systolic pressure, both detected through a doppler probe and a sphygmomanometer.\n\nNormal ABI ranges from 1.0 to 1.4. ABI values above 1.4 suggest a noncompressible calcified vessel. ABI value below 0.9 is considered diagnostic of PAD.","timeFrame":"6 months"},{"measure":"Sexual Hormonal Profile","description":"Sexual hormone binding protein after 6 months","timeFrame":"6 months"},{"measure":"Male Sexual Function","description":"Erectile function (IIEF-5) score at 6 months Male patients will perform a self-assessment test (IIEF-5) of their erectile function and overall satisfaction with sexual life, referring to the previous 6 months.\n\nErectile dysfunction (ED) will be classified based on the total questionnaire score. The highest score available is 25, the lowest is 0. Any score ranging from 25 and 22 refers to the absence of ED.\n\nAny score ≤ 21 will indicate the presence of ED \\[mild (score 21-17), mild-moderate (score 16 -12), moderate (score 11-8) and severe (score 7-1)\\].\n\nThe IIEF-5 questionnaire will be administered at visit 2 (week 0) and at the end of the study (week 24).","timeFrame":"6 months"},{"measure":"Female Sexual Function","description":"Female sexual function (FSFI) after 6 months Female sexual function will be studied through the FSFI questionnaire which assesses sexual activity over the past 4 weeks and includes 19 questions. The questionnaire will investigate six distinct domains (sexual desire, arousal, lubrication, orgasm, satisfaction and pain), and provide a total score indicative of global sexual function.\n\nPoints are assigned for each answer (from 1 to 5 for 1-2 questions, from 0 to 5 for 3-19): the sum of the scores for each domain is multiplied by a domain factor (desire 0.6, arousal 0.3, lubrication 0.3 orgasm 0.4, satisfaction 0.4, pain 0.4). The six domain scores are added up, and the total score may vary from 2.0 to 36.0 points.\n\nA total FSFI score \\< 26.55 will be used to classify the presence of female sexual dysfunction. The FSFI questionnaire will be administered at visit 2 (week 0) and at the end of the study (week 24).","timeFrame":"6 months"},{"measure":"6-minute Walking Test","description":"6-minutes walking distance after 6 months","timeFrame":"6 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* diagnosis of type 2 diabetes within at least 6 months\n* peripheral arterial disease documented within al least 1 year by doppler ultrasound, angio-CT or arteriography\n* peripheral transcutaneous oxygen pressure between 30 and 49 mmHg on anterior and/or posterior tibial arteries\n* Hba1c 6,5-8%\n* treatment of diabetes with metformin, insulin and/or sulfonylurea\n\nExclusion Criteria:\n\n* diagnosis of type 1 diabetes\n* current treatment with GLP-1 receptor agonists (GLP-1RAs) or dipeptidyl peptidase -4 (DPP-4) inhibitors\n* GLP-1RAs allergy or intolerance\n* participation to other clinical studies\n* history of pancreatitis, thyroid disease, diabetic gastroparesis or inflammatory bowel disease\n* current or planned pregnancy\n* acute myocardial infarction and/or acute cerebrovascular disease within 14 days from the screening visit\n* planned revascularization procedure\n* renal function with estimated glomerular filtration rate (eGFR) below 15 ml/min\n* history of cancer and/or oncological treatment within 5 years from the screening visit\n* current treatment with corticosteroids\n* psychiatric or other clinical conditions which may interfere with the study","healthyVolunteers":false,"sex":"ALL","minimumAge":"35 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Katherine Esposito, MD, PhD","affiliation":"University of Campania Luigi Vanvitelli","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Unit of Endocrinology and Metabolic Diseases and Unit of Diabetes, University of Campania Luigi Vanvitelli","city":"Naples","zip":"80138","country":"Italy","geoPoint":{"lat":40.85216,"lon":14.26811}}]},"referencesModule":{"references":[{"pmid":"36812501","type":"RESULT","citation":"Caruso P, Maiorino MI, Bellastella G, Esposito K, Giugliano D. Pleiotropic effects of GLP-1 receptor agonists on peripheral artery disease: Is there any hope? Diabetes Metab Res Rev. 2023 Oct;39(7):e3627. doi: 10.1002/dmrr.3627. Epub 2023 Mar 4. No abstract available."},{"pmid":"38470420","type":"DERIVED","citation":"Caruso P, Maiorino MI, Longo M, Porcellini C, Matrone R, Digitale Selvaggio L, Gicchino M, Carbone C, Scappaticcio L, Bellastella G, Giugliano D, Esposito K. Liraglutide for Lower Limb Perfusion in People With Type 2 Diabetes and Peripheral Artery Disease: The STARDUST Randomized Clinical Trial. JAMA Netw Open. 2024 Mar 4;7(3):e241545. doi: 10.1001/jamanetworkopen.2024.1545."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Liraglutide Group","description":"Patients in this arm will receive liraglutide, according to the current clinical practice.\n\nLiraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one."},{"id":"FG001","title":"Control Group","description":"Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.\n\nControl: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"30"},{"groupId":"FG001","numSubjects":"30"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"27"},{"groupId":"FG001","numSubjects":"28"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Liraglutide Group","description":"Patients in this arm will receive liraglutide, according to the current clinical practice.\n\nLiraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one."},{"id":"BG001","title":"Control Group","description":"Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.\n\nControl: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"55"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEDIAN","dispersionType":"INTER_QUARTILE_RANGE","unitOfMeasure":"years","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"55"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"66","lowerLimit":"62.5","upperLimit":"72.0"},{"groupId":"BG001","value":"65.0","lowerLimit":"60.0","upperLimit":"73.0"},{"groupId":"BG002","value":"65","lowerLimit":"61","upperLimit":"73"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"55"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"12"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"43"}]}]}]},{"title":"Race and Ethnicity Not Collected","populationDescription":"Race and Ethnicity were not collected from any participant.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}],"categories":[{"measurements":[{"groupId":"BG002","value":"0"}]}]}]},{"title":"Duration of diabetes","paramType":"MEDIAN","dispersionType":"INTER_QUARTILE_RANGE","unitOfMeasure":"years","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"55"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"11.0","lowerLimit":"5.5","upperLimit":"25"},{"groupId":"BG001","value":"10.0","lowerLimit":"3","upperLimit":"30"},{"groupId":"BG002","value":"10","lowerLimit":"4","upperLimit":"30"}]}]}]},{"title":"TcPO2","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmHg","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"55"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"40.0","spread":"5.9"},{"groupId":"BG001","value":"40.5","spread":"5.7"},{"groupId":"BG002","value":"40.3","spread":"5.8"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Peripheral Transcutaneous Oxygen Pressure","description":"Transcutaneous oxygen pressure (mmHg) on the lowest value recorded on anterior or posterior tibial artery after 6 months","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmHg","timeFrame":"6 months","groups":[{"id":"OG000","title":"Liraglutide Group","description":"Patients in this arm will receive liraglutide, according to the current clinical practice.\n\nLiraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one."},{"id":"OG001","title":"Control Group","description":"Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.\n\nControl: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"54.2","spread":"5.9"},{"groupId":"OG001","value":"43.4","spread":"4.8"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"t-test, 2 sided","paramType":"Mean Difference (Final Values)","paramValue":"11.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"8.0","ciUpperLimit":"14.5","otherAnalysisDescription":"To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \\< .05 was considered statistically significant."},{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Chi-squared","paramType":"Risk Ratio (RR)","paramValue":"1.91","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.26","ciUpperLimit":"2.90","otherAnalysisDescription":"To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \\< .05 was considered statistically significant."}]},{"type":"SECONDARY","title":"HbA1c Glucose Control","description":"HbA1c values after 6 months","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage of HbA1c","timeFrame":"6 months","groups":[{"id":"OG000","title":"Liraglutide Group","description":"Patients in this arm will receive liraglutide, according to the current clinical practice.\n\nLiraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one."},{"id":"OG001","title":"Control Group","description":"Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.\n\nControl: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.7","spread":"0.7"},{"groupId":"OG001","value":"6.8","spread":"0.8"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.06","statisticalMethod":"t-test, 2 sided","paramType":"Mean Difference (Final Values)","paramValue":"-0.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.8","ciUpperLimit":"0.01","otherAnalysisDescription":"To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \\< .05 was considered statistically significant."}]},{"type":"SECONDARY","title":"Glucose Control","description":"fasting glucose differences between groups","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"mg/dL","timeFrame":"6 months","groups":[{"id":"OG000","title":"Liraglutide Group","description":"Patients in this arm will receive liraglutide, according to the current clinical practice.\n\nLiraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one."},{"id":"OG001","title":"Control Group","description":"Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.\n\nControl: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"118.5","lowerLimit":"91","upperLimit":"132.5"},{"groupId":"OG001","value":"117","lowerLimit":"98","upperLimit":"122"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.52","statisticalMethod":"t-test, 2 sided","paramType":"Mean Difference (Final Values)","paramValue":"-3.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-14.3","ciUpperLimit":"7.4","otherAnalysisDescription":"To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \\< .05 was considered statistically significant."}]},{"type":"SECONDARY","title":"Weight Change","description":"Weight value at 6 months minus value at baseline","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kg","timeFrame":"6 months","groups":[{"id":"OG000","title":"Liraglutide Group","description":"Patients in this arm will receive liraglutide, according to the current clinical practice.\n\nLiraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one."},{"id":"OG001","title":"Control Group","description":"Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.\n\nControl: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"78.5","spread":"14.4"},{"groupId":"OG001","value":"80.7","spread":"12.5"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.33","statisticalMethod":"t-test, 2 sided","paramType":"Mean Difference (Final Values)","paramValue":"-1.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.6","ciUpperLimit":"1.2","otherAnalysisDescription":"To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \\< .05 was considered statistically significant."}]},{"type":"SECONDARY","title":"BMI Change","description":"BMI value at 6 months minus value at baseline","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kg/m2","timeFrame":"6 months","groups":[{"id":"OG000","title":"Liraglutide Group","description":"Patients in this arm will receive liraglutide, according to the current clinical practice.\n\nLiraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one."},{"id":"OG001","title":"Control Group","description":"Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.\n\nControl: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"28.7","spread":"4"},{"groupId":"OG001","value":"27.7","spread":"4.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.10","statisticalMethod":"t-test, 2 sided","paramType":"Mean Difference (Final Values)","paramValue":"-0.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.7","ciUpperLimit":"0.1","otherAnalysisDescription":"To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \\< .05 was considered statistically significant."}]},{"type":"SECONDARY","title":"Waist Circumference Change","description":"Waist circumference value at 6 months minus value at baseline","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"cm","timeFrame":"6 months","groups":[{"id":"OG000","title":"Liraglutide Group","description":"Patients in this arm will receive liraglutide, according to the current clinical practice.\n\nLiraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one."},{"id":"OG001","title":"Control Group","description":"Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.\n\nControl: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"108.9","spread":"10.3"},{"groupId":"OG001","value":"104.1","spread":"11.6"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.81","statisticalMethod":"t-test, 2 sided","paramType":"Mean Difference (Final Values)","paramValue":"0.36","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.8","ciUpperLimit":"3.5","otherAnalysisDescription":"To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \\< .05 was considered statistically significant."}]},{"type":"SECONDARY","title":"Systolic Blood Pressure Change","description":"systolic blood pressure value at 6 months minus value at baseline","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"mmHg","timeFrame":"6 months","groups":[{"id":"OG000","title":"Liraglutide Group","description":"Patients in this arm will receive liraglutide, according to the current clinical practice.\n\nLiraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one."},{"id":"OG001","title":"Control Group","description":"Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.\n\nControl: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"130","lowerLimit":"120","upperLimit":"130"},{"groupId":"OG001","value":"130","lowerLimit":"125","upperLimit":"140"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.99","statisticalMethod":"t-test, 2 sided","paramType":"Mean Difference (Final Values)","paramValue":"-0.003","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.8","ciUpperLimit":"5.8","otherAnalysisDescription":"To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \\< .05 was considered statistically significant."}]},{"type":"SECONDARY","title":"Lipid Profile","description":"total cholesterol after 6 months","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/dL","timeFrame":"6 months","groups":[{"id":"OG000","title":"Liraglutide Group","description":"Patients in this arm will receive liraglutide, according to the current clinical practice.\n\nLiraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one."},{"id":"OG001","title":"Control Group","description":"Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.\n\nControl: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"142.3","spread":"40.6"},{"groupId":"OG001","value":"158.8","spread":"55.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.72","statisticalMethod":"t-test, 2 sided","paramType":"Mean Difference (Final Values)","paramValue":"-4.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-32.6","ciUpperLimit":"22.9","otherAnalysisDescription":"To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \\< .05 was considered statistically significant."}]},{"type":"SECONDARY","title":"C-reactive Protein (CRP) Change","description":"CRP value at 6 months minus value at baseline","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/dL","timeFrame":"6 months","groups":[{"id":"OG000","title":"Liraglutide Group","description":"Patients in this arm will receive liraglutide, according to the current clinical practice.\n\nLiraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one."},{"id":"OG001","title":"Control Group","description":"Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.\n\nControl: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.5","spread":"0.5"},{"groupId":"OG001","value":"0.8","spread":"0.5"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.02","statisticalMethod":"t-test, 2 sided","paramType":"Mean Difference (Final Values)","paramValue":"-0.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.7","ciUpperLimit":"-0.07","otherAnalysisDescription":"To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \\< .05 was considered statistically significant."}]},{"type":"SECONDARY","title":"Renal Function","description":"creatinine levels after 6 months","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"mg/dL","timeFrame":"6 months","groups":[{"id":"OG000","title":"Liraglutide Group","description":"Patients in this arm will receive liraglutide, according to the current clinical practice.\n\nLiraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one."},{"id":"OG001","title":"Control Group","description":"Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.\n\nControl: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1","lowerLimit":"0.8","upperLimit":"1.2"},{"groupId":"OG001","value":"0.8","lowerLimit":"0.8","upperLimit":"1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.12","statisticalMethod":"t-test, 2 sided","paramType":"Mean Difference (Final Values)","paramValue":"0.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.04","ciUpperLimit":"0.3","otherAnalysisDescription":"To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \\< .05 was considered statistically significant."}]},{"type":"SECONDARY","title":"Estimated Glomerular Filtration Rate","description":"estimated glomerular filtration rate after 6 months","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mL/min/1.73 m^2","timeFrame":"6 months","groups":[{"id":"OG000","title":"Liraglutide Group","description":"Patients in this arm will receive liraglutide, according to the current clinical practice.\n\nLiraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one."},{"id":"OG001","title":"Control Group","description":"Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.\n\nControl: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"71","spread":"18.4"},{"groupId":"OG001","value":"74.7","spread":"13.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.25","statisticalMethod":"t-test, 2 sided","paramType":"Mean Difference (Final Values)","paramValue":"-3.09","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-8.5","ciUpperLimit":"2.3","otherAnalysisDescription":"To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \\< .05 was considered statistically significant."}]},{"type":"SECONDARY","title":"Angiogenesis","description":"vascular endothelial growth factor (VEGF) after 6 months","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"pg/mL","timeFrame":"6 months","groups":[{"id":"OG000","title":"Liraglutide Group","description":"Patients in this arm will receive liraglutide, according to the current clinical practice.\n\nLiraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one."},{"id":"OG001","title":"Control Group","description":"Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.\n\nControl: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"124","lowerLimit":"77.5","upperLimit":"188"},{"groupId":"OG001","value":"68.4","lowerLimit":"52.2","upperLimit":"80.8"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"t-test, 2 sided","paramType":"Mean Difference (Final Values)","paramValue":"87.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"59.9","ciUpperLimit":"115.1","otherAnalysisDescription":"To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \\< .05 was considered statistically significant."}]},{"type":"SECONDARY","title":"Ankle-brachial Index (ABI) Change","description":"ABI value after 6 months minus value at baseline ABI evaluation was obtained dividing the leg systolic pressure by the arm systolic pressure, both detected through a doppler probe and a sphygmomanometer.\n\nNormal ABI ranges from 1.0 to 1.4. ABI values above 1.4 suggest a noncompressible calcified vessel. ABI value below 0.9 is considered diagnostic of PAD.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"ratio","timeFrame":"6 months","groups":[{"id":"OG000","title":"Liraglutide Group","description":"Patients in this arm will receive liraglutide, according to the current clinical practice.\n\nLiraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one."},{"id":"OG001","title":"Control Group","description":"Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.\n\nControl: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.9","lowerLimit":"0.9","upperLimit":"1"},{"groupId":"OG001","value":"1","lowerLimit":"0.9","upperLimit":"1.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.18","statisticalMethod":"t-test, 2 sided","paramType":"Mean Difference (Final Values)","paramValue":"-0.03","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.09","ciUpperLimit":"0.01","otherAnalysisDescription":"To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \\< .05 was considered statistically significant."}]},{"type":"SECONDARY","title":"Sexual Hormonal Profile","description":"Sexual hormone binding protein after 6 months","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"nmol/L","timeFrame":"6 months","groups":[{"id":"OG000","title":"Liraglutide Group","description":"Patients in this arm will receive liraglutide, according to the current clinical practice.\n\nLiraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one."},{"id":"OG001","title":"Control Group","description":"Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.\n\nControl: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"45","lowerLimit":"34.1","upperLimit":"51.7"},{"groupId":"OG001","value":"49.5","lowerLimit":"44.5","upperLimit":"66.2"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.06","statisticalMethod":"t-test, 2 sided","paramType":"Mean Difference (Final Values)","paramValue":"8.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.6","ciUpperLimit":"18.1","otherAnalysisDescription":"To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \\< .05 was considered statistically significant."}]},{"type":"SECONDARY","title":"Male Sexual Function","description":"Erectile function (IIEF-5) score at 6 months Male patients will perform a self-assessment test (IIEF-5) of their erectile function and overall satisfaction with sexual life, referring to the previous 6 months.\n\nErectile dysfunction (ED) will be classified based on the total questionnaire score. The highest score available is 25, the lowest is 0. Any score ranging from 25 and 22 refers to the absence of ED.\n\nAny score ≤ 21 will indicate the presence of ED \\[mild (score 21-17), mild-moderate (score 16 -12), moderate (score 11-8) and severe (score 7-1)\\].\n\nThe IIEF-5 questionnaire will be administered at visit 2 (week 0) and at the end of the study (week 24).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"6 months","groups":[{"id":"OG000","title":"Liraglutide Group","description":"Patients in this arm will receive liraglutide, according to the current clinical practice.\n\nLiraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one."},{"id":"OG001","title":"Control Group","description":"Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.\n\nControl: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"22"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12.4","spread":"5.7"},{"groupId":"OG001","value":"12.5","spread":"4.6"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.06","statisticalMethod":"t-test, 2 sided","paramType":"Mean Difference (Final Values)","paramValue":"1.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.09","ciUpperLimit":"2.6","otherAnalysisDescription":"To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \\< .05 was considered statistically significant."}]},{"type":"SECONDARY","title":"Female Sexual Function","description":"Female sexual function (FSFI) after 6 months Female sexual function will be studied through the FSFI questionnaire which assesses sexual activity over the past 4 weeks and includes 19 questions. The questionnaire will investigate six distinct domains (sexual desire, arousal, lubrication, orgasm, satisfaction and pain), and provide a total score indicative of global sexual function.\n\nPoints are assigned for each answer (from 1 to 5 for 1-2 questions, from 0 to 5 for 3-19): the sum of the scores for each domain is multiplied by a domain factor (desire 0.6, arousal 0.3, lubrication 0.3 orgasm 0.4, satisfaction 0.4, pain 0.4). The six domain scores are added up, and the total score may vary from 2.0 to 36.0 points.\n\nA total FSFI score \\< 26.55 will be used to classify the presence of female sexual dysfunction. The FSFI questionnaire will be administered at visit 2 (week 0) and at the end of the study (week 24).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"6 months","groups":[{"id":"OG000","title":"Liraglutide Group","description":"Patients in this arm will receive liraglutide, according to the current clinical practice.\n\nLiraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one."},{"id":"OG001","title":"Control Group","description":"Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.\n\nControl: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"20.4","spread":"1.4"},{"groupId":"OG001","value":"21.2","spread":"1.3"}]}]}]},{"type":"SECONDARY","title":"6-minute Walking Test","description":"6-minutes walking distance after 6 months","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"meters","timeFrame":"6 months","groups":[{"id":"OG000","title":"Liraglutide Group","description":"Patients in this arm will receive liraglutide, according to the current clinical practice.\n\nLiraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one."},{"id":"OG001","title":"Control Group","description":"Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.\n\nControl: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"364","spread":"13.7"},{"groupId":"OG001","value":"340","spread":"11.5"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"t-test, 2 sided","paramType":"Mean Difference (Final Values)","paramValue":"25.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"21.8","ciUpperLimit":"28.3","otherAnalysisDescription":"To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \\< .05 was considered statistically significant."}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"6 months","description":"No adverse events occurred.","eventGroups":[{"id":"EG000","title":"Liraglutide Group","description":"Patients in this arm will receive liraglutide, according to the current clinical practice.\n\nLiraglutide: Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one.","deathsNumAffected":0,"deathsNumAtRisk":27,"seriousNumAffected":0,"seriousNumAtRisk":27,"otherNumAffected":0,"otherNumAtRisk":27},{"id":"EG001","title":"Control Group","description":"Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.\n\nControl: Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice.","deathsNumAffected":0,"deathsNumAtRisk":28,"seriousNumAffected":0,"seriousNumAtRisk":28,"otherNumAffected":0,"otherNumAtRisk":28}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Prof. Katherine Esposito, Head of the Division of Endocrinology and Metabolic Diseases","organization":"University of Campania Luigi Vanvitelli","email":"katherine.esposito@unicampania.it","phone":"+390815665031"}}},"documentSection":{"largeDocumentModule":{"noSap":true,"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2021-01-13","uploadDate":"2025-01-23T04:25","filename":"Prot_000.pdf","size":569859}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D003924","term":"Diabetes Mellitus, Type 2"},{"id":"D058729","term":"Peripheral Arterial Disease"},{"id":"D007249","term":"Inflammation"}],"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":"D050197","term":"Atherosclerosis"},{"id":"D001161","term":"Arteriosclerosis"},{"id":"D001157","term":"Arterial Occlusive Diseases"},{"id":"D014652","term":"Vascular Diseases"},{"id":"D002318","term":"Cardiovascular Diseases"},{"id":"D016491","term":"Peripheral Vascular Diseases"},{"id":"D010335","term":"Pathologic Processes"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}]},"interventionBrowseModule":{"meshes":[{"id":"D000069450","term":"Liraglutide"},{"id":"D035061","term":"Control Groups"}],"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":"D015340","term":"Epidemiologic Research Design"},{"id":"D004812","term":"Epidemiologic Methods"},{"id":"D008919","term":"Investigative Techniques"},{"id":"D012107","term":"Research Design"},{"id":"D008722","term":"Methods"}]}},"hasResults":true}