A Prospective Randomized, Double Blind, Placebo-controlled, Safety and Efficacy Study of Metformin as add-on Therapy in Non-diabetic Patients With Abdominal Aortic Aneurysm (MetAAA Study)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- AAA growth over 12 months in mm
研究概览
简要总结
A prospective randomized, double blind, placebo-controlled, safety and efficacy study of metformin as add-on therapy in abdominal aortic aneurysm (AAA)
OBJECTIVES Primary Objective
- To demonstrate treatment efficacy of metformin in AAA in comparison to placebo or active comparator, as measured by growth of the AAA maximum diameter at 12 months Secondary Objectives
- To asses inflammatory cytokines and parameters of neutrophil activation in AAA in response to metformin treatment by glucose
- insulin
- Interleukin-6
- markers of neutrophil activation (MPO, elastase, NGAL)
详细描述
DESIGN / PHASE Prospective, single-center, randomized, parallel group, double-blind, placebo controlled, phase IIa study STUDY PLANNED DURATION First patient First visit Year 1 1Q
Last patient First visit Year 2 4Q Last patient Last visit Year 3 2Q
CENTER(S)
-
COUNTRY(IES) 1 center in 1 country Austria PATIENTS / GROUPS 170 patients in 2 groups 85 patients per group Randomization ratio 1:1 Stratification for hypertension, age, smoking habit, sex INCLUSION CRITERIA
-
Infrarenal AAA of 3.0-4.9 cm maximum diameter EXCLUSION CRITERIA
-
premenopausal female patients with a pregnancy possibility
-
patients with diabetes
-
indication for surgical AAA repair
-
life expectancy <2 years
-
contraindications for metformin, i.e. severely reduced kidney function (eGFR <30 ml/min), liver dysfunction, pancreatitis, alcohol abuse, malnutrition and decompensated heart failure STUDY PERIODS
-
1-2 year recruitment
-
1 year treatment
-
12 month follow-up INVESTIGATIONAL DRUG
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infrarenal AAA of 3-4.9 cm maximum diameter
排除标准
- •premenopausal female patients with a pregnancy possibility
- •patients with diabetes
- •indication for surgical AAA repair
- •contraindications for metformin, i.e. severly reduced kidney function (eGFR <30 ml/min), liver dysfunction, pancreatitis, alcohol abusus, malnutrition and decompensated heart failure
研究组 & 干预措施
INVESTIGATIONAL DRUG
oral metformin treatment with 2000Mg daily: Glucophage 500mg Tablet (2-0-2) daily for 1 year
干预措施: Metformin Glucophage 500mg (IR) tablets M90 (Drug)
COMPARATIVE DRUG
Placebo matching M90 Oral Tablet treatment twice daily (2-0-2) for 1 year
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
AAA growth over 12 months in mm
时间窗: 12 months
AAA maximum diameter in CT scan
次要结局
- glucose markers insulin and glucose(12 months)
- inflammation markers IL-6(12 months)
- neutrophil markers NGAL(12 months)
- ineutrophil marker MPO(12 months)
- neutrophil marker elastase(12 months)
- AAA thrombus(12 months)
研究者
Christoph Neumayer
Professor, MD
Medical University of Vienna