search
Back to results

Liraglutide and Peripheral Artery Disease (STARDUST)

Primary Purpose

Type 2 Diabetes, Peripheral Arterial Disease

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Liraglutide
Control
Sponsored by
University of Campania "Luigi Vanvitelli"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Liraglutide, Transcutaneous Oxygen Tension, Peripheral arterial disease, Inflammation, Angiogenesis, Endothelial Dysfunction, Diabetic microvascular complications

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Unit of Endocrinology and Metabolic Diseases and Unit of Diabetes, University of Campania Luigi VanvitelliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Liraglutide group

Control group

Arm Description

Patients in this arm will receive liraglutide, according to the current clinical practice.

Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.

Outcomes

Primary Outcome Measures

Peripheral transcutaneous oxygen pressure
Change in transcutaneous oxygen pressure (mmHg) on anterior and posterior tibial arteries

Secondary Outcome Measures

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

Full Information

First Posted
May 6, 2021
Last Updated
June 9, 2021
Sponsor
University of Campania "Luigi Vanvitelli"
search

1. Study Identification

Unique Protocol Identification Number
NCT04881110
Brief Title
Liraglutide and Peripheral Artery Disease
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 28, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campania "Luigi Vanvitelli"

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Peripheral Arterial Disease
Keywords
Type 2 diabetes, Liraglutide, Transcutaneous Oxygen Tension, Peripheral arterial disease, Inflammation, Angiogenesis, Endothelial Dysfunction, Diabetic microvascular complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liraglutide group
Arm Type
Experimental
Arm Description
Patients in this arm will receive liraglutide, according to the current clinical practice.
Arm Title
Control group
Arm Type
Other
Arm Description
Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Other Intervention Name(s)
Intervention group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Peripheral transcutaneous oxygen pressure
Description
Change in transcutaneous oxygen pressure (mmHg) on anterior and posterior tibial arteries
Time Frame
3 and 6 months
Secondary Outcome Measure Information:
Title
HbA1c Glucose control
Time Frame
3 and 6 months
Title
Glucose control
Description
fasting glucose differences between groups
Time Frame
3 and 6 months
Title
Weight change
Time Frame
3 and 6 months
Title
BMI change
Time Frame
3 and 6 months
Title
Waist circumference change
Time Frame
3 and 6 months
Title
Blood pressure change
Time Frame
3 and 6 months
Title
Lipid profile
Description
Difference between groups in total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides
Time Frame
3 and 6 months
Title
Inflammation
Description
Difference between groups in C reactive protein, fibrinogen, Tumor Necrosis Factor-alpha (TNF-alpha) and Interleukin (IL)-6
Time Frame
6 months
Title
Renal function
Description
Difference between groups in creatininemia, uremia, albuminuria level
Time Frame
3 and 6 months
Title
estimated glomerular filtration rate
Description
Renal function
Time Frame
3 and 6 months
Title
Angiogenesis
Description
Difference between groups in endothelial progenitors cells circulating levels and vascular endothelial growth factor (VEGF)
Time Frame
6 months
Title
Ankle-brachial Index (ABI) change
Description
Difference between groups in ABI
Time Frame
6 months
Title
Sexual hormonal profile
Description
Difference between groups in sexual hormones levels [testosterone/estradiol, follicle stimulating hormone (FSH), luteinizing hormone (LH), SHBG)
Time Frame
6 months
Title
Male sexual function
Description
Difference between groups in Erectile function (IIEF-5)
Time Frame
6 months
Title
Female sexual function
Description
Difference between groups in Female sexual function (FSFI)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine Esposito, MD, PhD
Phone
+39 0815665031
Email
katherine.esposito@unicampania.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Esposito, MD, PhD
Organizational Affiliation
University of Campania "Luigi Vanvitelli"
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit of Endocrinology and Metabolic Diseases and Unit of Diabetes, University of Campania Luigi Vanvitelli
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Esposito, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Liraglutide and Peripheral Artery Disease

We'll reach out to this number within 24 hrs