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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.
The 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.
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.
Data 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide group | Experimental | Patients in this arm will receive liraglutide, according to the current clinical practice. |
|
| Control group | Other | Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral Transcutaneous Oxygen Pressure | Transcutaneous oxygen pressure (mmHg) on the lowest value recorded on anterior or posterior tibial artery after 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Glucose Control | HbA1c values after 6 months | 6 months |
| Glucose Control | fasting glucose differences between groups | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Esposito, MD, PhD | University of Campania Luigi Vanvitelli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Endocrinology and Metabolic Diseases and Unit of Diabetes, University of Campania Luigi Vanvitelli | Naples | 80138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36812501 | Result | 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. | |
| 38470420 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liraglutide Group | Patients in this arm will receive liraglutide, according to the current clinical practice. Liraglutide: 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. |
| FG001 | Control Group | Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors. Control: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Liraglutide Group | Patients in this arm will receive liraglutide, according to the current clinical practice. Liraglutide: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Peripheral Transcutaneous Oxygen Pressure | Transcutaneous oxygen pressure (mmHg) on the lowest value recorded on anterior or posterior tibial artery after 6 months | Posted | Mean | Standard Deviation | mmHg | 6 months |
|
6 months
No adverse events occurred.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liraglutide Group | Patients in this arm will receive liraglutide, according to the current clinical practice. Liraglutide: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Katherine Esposito, Head of the Division of Endocrinology and Metabolic Diseases | University of Campania Luigi Vanvitelli | +390815665031 | katherine.esposito@unicampania.it |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 13, 2021 | Jan 23, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D058729 | Peripheral Arterial Disease |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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|
| Control | Other | 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. |
|
|
| 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 |
| BG001 |
| Control Group |
Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors. Control: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Duration of diabetes | Median | Inter-Quartile Range | years |
|
| TcPO2 | Mean | Standard Deviation | mmHg |
|
|
|
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| Secondary | HbA1c Glucose Control | HbA1c values after 6 months | Posted | Mean | Standard Deviation | percentage of HbA1c | 6 months |
|
|
|
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| Secondary | Glucose Control | fasting glucose differences between groups | Posted | Median | Inter-Quartile Range | mg/dL | 6 months |
|
|
|
|
| Secondary | Weight Change | Weight value at 6 months minus value at baseline | Posted | Mean | Standard Deviation | Kg | 6 months |
|
|
|
|
| Secondary | BMI Change | BMI value at 6 months minus value at baseline | Posted | Mean | Standard Deviation | Kg/m2 | 6 months |
|
|
|
|
| Secondary | Waist Circumference Change | Waist circumference value at 6 months minus value at baseline | Posted | Mean | Standard Deviation | cm | 6 months |
|
|
|
|
| Secondary | Systolic Blood Pressure Change | systolic blood pressure value at 6 months minus value at baseline | Posted | Median | Inter-Quartile Range | mmHg | 6 months |
|
|
|
|
| Secondary | Lipid Profile | total cholesterol after 6 months | Posted | Mean | Standard Deviation | mg/dL | 6 months |
|
|
|
|
| Secondary | C-reactive Protein (CRP) Change | CRP value at 6 months minus value at baseline | Posted | Mean | Standard Deviation | mg/dL | 6 months |
|
|
|
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| Secondary | Renal Function | creatinine levels after 6 months | Posted | Median | Inter-Quartile Range | mg/dL | 6 months |
|
|
|
|
| Secondary | Estimated Glomerular Filtration Rate | estimated glomerular filtration rate after 6 months | Posted | Mean | Standard Deviation | mL/min/1.73 m^2 | 6 months |
|
|
|
|
| Secondary | Angiogenesis | vascular endothelial growth factor (VEGF) after 6 months | Posted | Median | Inter-Quartile Range | pg/mL | 6 months |
|
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | ratio | 6 months |
|
|
|
|
| Secondary | Sexual Hormonal Profile | Sexual hormone binding protein after 6 months | Posted | Median | Inter-Quartile Range | nmol/L | 6 months |
|
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| Secondary | 6-minute Walking Test | 6-minutes walking distance after 6 months | Posted | Mean | Standard Deviation | meters | 6 months |
|
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Control Group | Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors. Control: 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. | 0 | 28 | 0 | 28 | 0 | 28 |
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| D004700 | Endocrine System Diseases |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |