Liraglutide and Peripheral Artery Disease

Phase 4

Completed

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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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

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	6 months	Transcutaneous oxygen pressure (mmHg) on the lowest value recorded on anterior or posterior tibial artery after 6 months

Secondary Outcome Measures

Name	Time	Method
HbA1c Glucose Control	6 months	HbA1c values after 6 months
Glucose Control	6 months	fasting glucose differences between groups
Weight Change	6 months	Weight value at 6 months minus value at baseline
BMI Change	6 months	BMI value at 6 months minus value at baseline
Waist Circumference Change	6 months	Waist circumference value at 6 months minus value at baseline
Systolic Blood Pressure Change	6 months	systolic blood pressure value at 6 months minus value at baseline
Lipid Profile	6 months	total cholesterol after 6 months
C-reactive Protein (CRP) Change	6 months	CRP value at 6 months minus value at baseline
Renal Function	6 months	creatinine levels after 6 months
Estimated Glomerular Filtration Rate	6 months	estimated glomerular filtration rate after 6 months
Angiogenesis	6 months	vascular endothelial growth factor (VEGF) after 6 months
Ankle-brachial Index (ABI) Change	6 months	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.
Sexual Hormonal Profile	6 months	Sexual hormone binding protein after 6 months
Male Sexual Function	6 months	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).
Female Sexual Function	6 months	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-minute Walking Test	6 months	6-minutes walking distance after 6 months