Clinical trial NCT04881110: Liraglutide and Peripheral Artery Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Peripheral Transcutaneous Oxygen Pressure
timeFrame: 6 months
Secondary outcomes:
measure: HbA1c Glucose Control
timeFrame: 6 months
measure: Glucose Control
timeFrame: 6 months
measure: Weight Change
timeFrame: 6 months
measure: BMI Change
timeFrame: 6 months
measure: Waist Circumference Change
timeFrame: 6 months
measure: Systolic Blood Pressure Change
timeFrame: 6 months
measure: Lipid Profile
timeFrame: 6 months
measure: C-reactive Protein (CRP) Change
timeFrame: 6 months
measure: Renal Function
timeFrame: 6 months
measure: Estimated Glomerular Filtration Rate
timeFrame: 6 months
measure: Angiogenesis
timeFrame: 6 months
measure: Ankle-brachial Index (ABI) Change
timeFrame: 6 months
measure: Sexual Hormonal Profile
timeFrame: 6 months
measure: Male Sexual Function
timeFrame: 6 months
measure: Female Sexual Function
timeFrame: 6 months
measure: 6-minute Walking Test
timeFrame: 6 months
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Unit of Endocrinology and Metabolic Diseases and Unit of Diabetes, University of Campania Luigi Vanvitelli
Study officials:
affiliation: University of Campania Luigi Vanvitelli
name: Katherine Esposito, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.