STARDUST: Liraglutide and Peripheral Artery Disease

Sponsor

University of Campania "Luigi Vanvitelli" (Other)

Overall Status

Recruiting

CT.gov ID

NCT04881110

Collaborator

(none)

Enrollment

Location

Arms

14.1

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Peripheral Arterial Disease	Drug: Liraglutide Other: Control	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 28, 2021

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Peripheral transcutaneous oxygen pressure [3 and 6 months]
Change in transcutaneous oxygen pressure (mmHg) on anterior and posterior tibial arteries

Secondary Outcome Measures

HbA1c Glucose control [3 and 6 months]
Glucose control [3 and 6 months]
fasting glucose differences between groups
Weight change [3 and 6 months]
BMI change [3 and 6 months]
Waist circumference change [3 and 6 months]
Blood pressure change [3 and 6 months]
Lipid profile [3 and 6 months]
Difference between groups in total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides
Inflammation [6 months]
Difference between groups in C reactive protein, fibrinogen, Tumor Necrosis Factor-alpha (TNF-alpha) and Interleukin (IL)-6
Renal function [3 and 6 months]
Difference between groups in creatininemia, uremia, albuminuria level
estimated glomerular filtration rate [3 and 6 months]
Renal function
Angiogenesis [6 months]
Difference between groups in endothelial progenitors cells circulating levels and vascular endothelial growth factor (VEGF)
Ankle-brachial Index (ABI) change [6 months]
Difference between groups in ABI
Sexual hormonal profile [6 months]
Difference between groups in sexual hormones levels [testosterone/estradiol, follicle stimulating hormone (FSH), luteinizing hormone (LH), SHBG)
Male sexual function [6 months]
Difference between groups in Erectile function (IIEF-5)
Female sexual function [6 months]
Difference between groups in Female sexual function (FSFI)

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Unit of Endocrinology and Metabolic Diseases and Unit of Diabetes, University of Campania Luigi Vanvitelli	Napoli		Italy	80138

Sponsors and Collaborators

University of Campania "Luigi Vanvitelli"

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Katherine Esposito, Professor of Endocrinology and Metabolic Diseases, Head of Unit of Diabetes, University of Campania "Luigi Vanvitelli"

ClinicalTrials.gov Identifier:

NCT04881110

Other Study ID Numbers:

2_0401_2021

First Posted:

May 11, 2021

Last Update Posted:

Jun 14, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Katherine Esposito, Professor of Endocrinology and Metabolic Diseases, Head of Unit of Diabetes, University of Campania "Luigi Vanvitelli"

Type 2 diabetes

Liraglutide

Transcutaneous Oxygen Tension

Peripheral arterial disease

Inflammation

Angiogenesis

Endothelial Dysfunction

Diabetic microvascular complications

Additional relevant MeSH terms:

Peripheral Arterial Disease

Peripheral Vascular Diseases

Diabetes Mellitus, Type 2

Liraglutide

Study Results

No Results Posted as of Jun 14, 2021