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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Peripheral Transcutaneous Oxygen Pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Liraglutide group
Patients in this arm will receive liraglutide, according to the current clinical practice.
干预措施: Liraglutide (Drug)
Control group
Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.
干预措施: Control (Other)
结局指标
主要结局
Peripheral Transcutaneous Oxygen Pressure
时间窗: 6 months
Transcutaneous oxygen pressure (mmHg) on the lowest value recorded on anterior or posterior tibial artery after 6 months
次要结局
- HbA1c Glucose Control(6 months)
- Glucose Control(6 months)
- Weight Change(6 months)
- BMI Change(6 months)
- Waist Circumference Change(6 months)
- Systolic Blood Pressure Change(6 months)
- Lipid Profile(6 months)
- C-reactive Protein (CRP) Change(6 months)
- Ankle-brachial Index (ABI) Change(6 months)
- Sexual Hormonal Profile(6 months)
- Renal Function(6 months)
- Estimated Glomerular Filtration Rate(6 months)
- Angiogenesis(6 months)
- Male Sexual Function(6 months)
- Female Sexual Function(6 months)
- 6-minute Walking Test(6 months)
研究者
Katherine Esposito
Professor of Endocrinology and Metabolic Diseases, Head of Unit of Diabetes
University of Campania Luigi Vanvitelli