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NCT Number: NCT04881110

Liraglutide and Peripheral Artery Disease

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.

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Key information

Conditions

Type 2 Diabetes Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Inflammation Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Unit of Endocrinology and Metabolic Diseases and Unit of Diabetes, University of Campania Luigi Vanvitelli

Naples, 80138, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

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 names: Intervention group

Control

Other

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.

Other names: Control group

Primary outcomes

  1. Peripheral Transcutaneous Oxygen Pressure

    Time frame: 6 months

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

Secondary outcomes

  1. HbA1c Glucose Control

    Time frame: 6 months

    HbA1c values after 6 months

  2. Glucose Control

    Time frame: 6 months

    fasting glucose differences between groups

  3. Weight Change

    Time frame: 6 months

    Weight value at 6 months minus value at baseline

  4. BMI Change

    Time frame: 6 months

    BMI value at 6 months minus value at baseline

  5. Waist Circumference Change

    Time frame: 6 months

    Waist circumference value at 6 months minus value at baseline

  6. Systolic Blood Pressure Change

    Time frame: 6 months

    systolic blood pressure value at 6 months minus value at baseline

  7. Lipid Profile

    Time frame: 6 months

    total cholesterol after 6 months

  8. C-reactive Protein (CRP) Change

    Time frame: 6 months

    CRP value at 6 months minus value at baseline

  9. Renal Function

    Time frame: 6 months

    creatinine levels after 6 months

  10. Estimated Glomerular Filtration Rate

    Time frame: 6 months

    estimated glomerular filtration rate after 6 months

  11. Angiogenesis

    Time frame: 6 months

    vascular endothelial growth factor (VEGF) after 6 months

  12. Ankle-brachial Index (ABI) Change

    Time frame: 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.

  13. Sexual Hormonal Profile

    Time frame: 6 months

    Sexual hormone binding protein after 6 months

  14. Male Sexual Function

    Time frame: 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).

  15. Female Sexual Function

    Time frame: 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).

  16. 6-minute Walking Test

    Time frame: 6 months

    6-minutes walking distance after 6 months

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study 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

Acronym: STARDUST

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 11, 2021
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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