Liraglutide and Peripheral Artery Disease

Type 2 Diabetes Clinical Trial

— STARDUST  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04881110
• Other study ID #: 2_0401_2021
• Status: Recruiting
• Phase: Phase 4
• Start date: April 28, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: June 2021
• Source: University of Campania "Luigi Vanvitelli"
• Contact: Katherine Esposito, MD, PhD
• Phone: +39 0815665031
• Email: katherine.esposito[@]unicampania.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Type 2 Diabetes

Intervention

Drug:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Italy	Unit of Endocrinology and Metabolic Diseases and Unit of Diabetes, University of Campania Luigi Vanvitelli	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

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