Liraglutide and Peripheral Artery Disease (STARDUST)

February 12, 2025 updated by: Katherine Esposito, University of Campania Luigi Vanvitelli

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Napoli, Italy, 80138
        • Unit of Endocrinology and Metabolic Diseases and Unit of Diabetes, University of Campania Luigi Vanvitelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liraglutide group
Patients in this arm will receive liraglutide, according to the current clinical practice.
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 Names:
  • Intervention group
Other: Control group
Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.
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.
Other Names:
  • Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania Luigi Vanvitelli

Investigators

  • Principal Investigator: Katherine Esposito, MD, PhD, University of Campania Luigi Vanvitelli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

May 6, 2021

First Submitted That Met QC Criteria

May 10, 2021

First Posted (Actual)

May 11, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2_0401_2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe