2024-517387-37-00招募中2 期
Metformin for Abdominal Aortic Aneurysm Inhibition (MAAAGI) A randomized controlled trial
Uppsala University12 个研究点 分布在 3 个国家目标入组 500 人开始时间: 2024年11月11日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 12
- 主要终点
- To examine if 2 g metformin administered daily over a five-year period slows AAA growth rate in patients with small AAAs who do not have diabetes mellitus measured as computed tomography (CT) imaging assessed AAA diameter. Measured at baseline versus 24 and 60 months of treatment.
研究概览
简要总结
To investigate if 2 g metformin daily over 60 months reduce yearly growth rate of small abdominal aortic aneurysms in patients with no history of diabetes. At 24 months a Stop/Go interim analysis will be performed for safety and efficacy.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Provision of written informed consent
- •Male and female patients
- •Age 50-80 years
- •Documented AAA Ø 30-49 mm for men and 30-44 mm for women
- •No history of diabetes mellitus and fasting p-glucose <7.0 mmol/L
排除标准
- •Short expected survival.
- •History of current or previous diabetes mellitus.
- •Current or previous use of metformin.
- •Not expected to tolerate metformin.
- •Contraindications to metformin treatment according to SmPC: a) Renal failure with glomerular filtration rate (GFR) <45ml/min according to the revised Lund-Malmö formula. b) Hypersenisitivity to metformin or any of the excipients included in the tablet. c) Acute metabolic acidosis. d) Diabetic pre-coma. e) Acute conditions with the potential to alter renal function such as; dehydration, severe infection or shock. f) Acute or chronic disease which may cause tissue hypoxia such as; decompensated heart failure, respiratory failure, recent myocardial infarction or shock. g) Hepatic insufficiency, acute alcohol intoxication, alcoholism.
- •Known or suspected connective tissue disorder (Marfans syndrome, etc), infected or inflammatory aneurysm, aneurysm development after aortic dissection or previous surgery of the infrarenal aorta.
- •Enrolment in either another investigational drug or medical device study or another investigational study of an approved drug or medical device within 30 days prior to enrolment of the current study.
- •If, in the opinion of the investigator, it is not in the patient's medical interest to participate in the study or the patient is unlikely to be able to comply with the study protocol.
- •Pregnancy. Women of childbearing potential are only included after a confirmed menstrual period and a negative highly sensitive urine or serum pregnancy test as well as willingness to comply with highly effective anti-contraception throughout the study period
结局指标
主要结局
To examine if 2 g metformin administered daily over a five-year period slows AAA growth rate in patients with small AAAs who do not have diabetes mellitus measured as computed tomography (CT) imaging assessed AAA diameter. Measured at baseline versus 24 and 60 months of treatment.
To examine if 2 g metformin administered daily over a five-year period slows AAA growth rate in patients with small AAAs who do not have diabetes mellitus measured as computed tomography (CT) imaging assessed AAA diameter. Measured at baseline versus 24 and 60 months of treatment.
次要结局
- To examine if metformin; a) limits increase in CT-assessed AAA volume; b) ultrasound assessed AAA diameter; c) improve health-related quality of life; and d) represent a cost-effective treatment to reduce the need for AAA surgery.
- Safety objective. To determine adverse events; primarily related to known side effects of metformin and possible unexpected effects on AAA, related to metformin treatment after two and five years treatment.
- Exploratory objectives. To examine; a) if there is a dose or time related response of metformin regarding the primary or secondary endpoints; and b) if metformin favorably modify circulating inflammation and matrix remodeling biomarkers; or c) affect perivascular adipose tissue.
研究者
Department of Surgical Sciences
Scientific
Uppsala University
研究点 (12)
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