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Clinical Trial Details

Trial ID: L3656
Source ID: NCT04881110
Associated Drug: Liraglutide
Title: Liraglutide and Peripheral Artery Disease
Acronym: STARDUST
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04881110/results
Conditions: Type 2 Diabetes|Peripheral Arterial Disease
Interventions: DRUG: Liraglutide|OTHER: Control
Outcome Measures: Primary: Peripheral Transcutaneous Oxygen Pressure, Transcutaneous oxygen pressure (mmHg) on the lowest value recorded on anterior or posterior tibial artery after 6 months, 6 months | Secondary: HbA1c Glucose Control, HbA1c values after 6 months, 6 months|Glucose Control, fasting glucose differences between groups, 6 months|Weight Change, Weight value at 6 months minus value at baseline, 6 months|BMI Change, BMI value at 6 months minus value at baseline, 6 months|Waist Circumference Change, Waist circumference value at 6 months minus value at baseline, 6 months|Systolic Blood Pressure Change, systolic blood pressure value at 6 months minus value at baseline, 6 months|Lipid Profile, total cholesterol after 6 months, 6 months|C-reactive Protein (CRP) Change, CRP value at 6 months minus value at baseline, 6 months|Renal Function, creatinine levels after 6 months, 6 months|Estimated Glomerular Filtration Rate, estimated glomerular filtration rate after 6 months, 6 months|Angiogenesis, vascular endothelial growth factor (VEGF) after 6 months, 6 months|Ankle-brachial Index (ABI) Change, 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. Normal 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., 6 months|Sexual Hormonal Profile, Sexual hormone binding protein after 6 months, 6 months|Male Sexual Function, 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. Erectile 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. Any score ≤ 21 will indicate the presence of ED \[mild (score 21-17), mild-moderate (score 16 -12), moderate (score 11-8) and severe (score 7-1)\]. The IIEF-5 questionnaire will be administered at visit 2 (week 0) and at the end of the study (week 24)., 6 months|Female Sexual Function, 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. Points 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. A 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)., 6 months|6-minute Walking Test, 6-minutes walking distance after 6 months, 6 months
Sponsor/Collaborators: Sponsor: University of Campania Luigi Vanvitelli
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-02-01
Completion Date: 2022-12-31
Results First Posted: 2025-03-03
Last Update Posted: 2025-03-03
Locations: Unit of Endocrinology and Metabolic Diseases and Unit of Diabetes, University of Campania Luigi Vanvitelli, Napoli, 80138, Italy
URL: https://clinicaltrials.gov/show/NCT04881110