NL-OMON51630招募中2 期
Metformin for AAA Growth Inhibition: A randomized controlled trial - MAAAGI trial
ppsala University0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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.
- •Fasting p-glucose <7.0 mmol/L (WHO 1999). Fasting is defined as no caloric
- •intake for >=8 h.
排除标准
- •1. Short expected survival.
- •2. History of current or previous diabetes mellitus.
- •3. Current or previous use of metformin.
- •4. Not expected to tolerate metformin.
- •5. Contraindications to metformin treatment according to SmPC:
- •- Renal failure with glomerular filtration rate (GFR) <45ml/min according to
- •the revised Lund-Malmo* formula.
- •- Hypersensitivity to metformin or any of the excipients included in the
- •- Acute metabolic acidosis.
- •- Diabetic pre-coma.
- •- Acute conditions with the potential to alter renal function such as;
- •dehydration, severe infection or shock.
- •- Acute or chronic disease which may cause tissue hypoxia such as;
- •decompensated heart failure, respiratory failure, recent myocardial infarction
- •- Hepatic insufficiency, acute alcohol intoxication, alcoholism.
- •6. 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.
- •7. 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.
- •8. 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.
- •9. 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.
研究者
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