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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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.
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.
Unit of Endocrinology and Metabolic Diseases and Unit of Diabetes, University of Campania Luigi Vanvitelli
Naples, Italy
Peripheral Transcutaneous Oxygen Pressure
Transcutaneous oxygen pressure (mmHg) on the lowest value recorded on anterior or posterior tibial artery after 6 months
Time frame: 6 months
HbA1c Glucose Control
HbA1c values after 6 months
Time frame: 6 months
Glucose Control
fasting glucose differences between groups
Time frame: 6 months
Weight Change
Weight value at 6 months minus value at baseline
Time frame: 6 months
BMI Change
BMI value at 6 months minus value at baseline
Time frame: 6 months
Waist Circumference Change
Waist circumference value at 6 months minus value at baseline
Time frame: 6 months
Systolic Blood Pressure Change
systolic blood pressure value at 6 months minus value at baseline
Time frame: 6 months
Lipid Profile
total cholesterol after 6 months
Time frame: 6 months
C-reactive Protein (CRP) Change
CRP value at 6 months minus value at baseline
Time frame: 6 months
Renal Function
creatinine levels after 6 months
Time frame: 6 months
Estimated Glomerular Filtration Rate
estimated glomerular filtration rate after 6 months
Time frame: 6 months
Angiogenesis
vascular endothelial growth factor (VEGF) after 6 months
Time frame: 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.
Time frame: 6 months
Sexual Hormonal Profile
Sexual hormone binding protein after 6 months
Time frame: 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).
Time frame: 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).
Time frame: 6 months
6-minute Walking Test
6-minutes walking distance after 6 months
Time frame: 6 months
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