Liraglutide and Peripheral Artery Disease

Sponsor
University of Campania Luigi Vanvitelli
Study ID
NCT04881110
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
35 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Feb 1, 2021
Status verified
Feb 2025
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Peripheral Transcutaneous Oxygen Pressure [ Time Frame: 6 months ]

Related coverage on Hipa.ai

Related Studies