Liraglutide and Peripheral Artery Disease

Phase 4

• Conditions: Type 2 Diabetes; Peripheral Arterial Disease
• Interventions: Other: Control; Drug: Liraglutide

• Registration Number: NCT04881110
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-28
• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-10
• Study First Posted: 2021-05-11
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-09
• Last Update Posted: 2021-06-14
• Primary Completion: 2021-12-31
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• diagnosis of type 2 diabetes within at least 6 months
• peripheral arterial disease documented within al least 1 year by doppler ultrasound, angio-CT or arteriography
• peripheral transcutaneous oxygen pressure between 30 and 49 mmHg on anterior and/or posterior tibial arteries
• Hba1c 6,5-8%
• treatment of diabetes with metformin, insulin and/or sulfonylurea

Read More

Exclusion Criteria

• diagnosis of type 1 diabetes
• current treatment with GLP-1 receptor agonists (GLP-1RAs) or dipeptidyl peptidase -4 (DPP-4) inhibitors
• GLP-1RAs allergy or intolerance
• participation to other clinical studies
• history of pancreatitis, thyroid disease, diabetic gastroparesis or inflammatory bowel disease
• current or planned pregnancy
• acute myocardial infarction and/or acute cerebrovascular disease within 14 days from the screening visit
• planned revascularization procedure
• renal function with estimated glomerular filtration rate (eGFR) below 15 ml/min
• history of cancer and/or oncological treatment within 5 years from the screening visit
• current treatment with corticosteroids
• psychiatric or other clinical conditions which may interfere with the study

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control	Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.
Liraglutide group	Liraglutide	Patients in this arm will receive liraglutide, according to the current clinical practice.

Primary Outcome Measures

Name	Time	Method
Peripheral transcutaneous oxygen pressure	3 and 6 months	Change in transcutaneous oxygen pressure (mmHg) on anterior and posterior tibial arteries

Secondary Outcome Measures

Name	Time	Method
Ankle-brachial Index (ABI) change	6 months	Difference between groups in ABI
Renal function	3 and 6 months	Difference between groups in creatininemia, uremia, albuminuria level
Angiogenesis	6 months	Difference between groups in endothelial progenitors cells circulating levels and vascular endothelial growth factor (VEGF)
HbA1c Glucose control	3 and 6 months
Weight change	3 and 6 months
Waist circumference change	3 and 6 months
Lipid profile	3 and 6 months	Difference between groups in total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides
Female sexual function	6 months	Difference between groups in Female sexual function (FSFI)
BMI change	3 and 6 months
Inflammation	6 months	Difference between groups in C reactive protein, fibrinogen, Tumor Necrosis Factor-alpha (TNF-alpha) and Interleukin (IL)-6
Glucose control	3 and 6 months	fasting glucose differences between groups
Blood pressure change	3 and 6 months
estimated glomerular filtration rate	3 and 6 months	Renal function
Sexual hormonal profile	6 months	Difference between groups in sexual hormones levels \[testosterone/estradiol, follicle stimulating hormone (FSH), luteinizing hormone (LH), SHBG)
Male sexual function	6 months	Difference between groups in Erectile function (IIEF-5)

Trial Locations

Locations (1)

Unit of Endocrinology and Metabolic Diseases and Unit of Diabetes, University of Campania Luigi Vanvitelli; 🇮🇹 Napoli, Italy