EUCTR2011-000300-18-GB进行中（未招募）1 期
REducing with MetfOrmin Vascular Adverse Lesions in T1DM (The REMOVAL study) - The REMOVAL study
HS Greater Glasgow and Clyde0 个研究点目标入组 493 人开始时间: 2011年8月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 493
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Type 1 Diabetes for five years or more* (defined as diagnosis below age 35 AND insulin use within 1 year of diagnosis)
- •- Age = 40 years
- •- 7.0 = HbA1c < 10.0% (53-86 mmol/mol)
- •AND three of more of the following ten CVD risk factors:
- •- BMI greater than 27kg/m^2
- •- current HbA1c > 8.0% (64mmol/mol)
- •- known CVD/peripheral vascular disease
- •- current smoker
- •- estimated glomerular filtration rate < 90 ml/min per 1.73 m^2
- •- confirmed micro- or macroalbuminuria [according to local assays and reference ranges]
- •- hypertension (BP of 140/90mmHg or above or established on antihypertensive treatment)
- •- dyslipidaemia [total cholesterol = 5.0 mmol/L (200 mg/dL); OR HDL cholesterol <1.2 (46 mg/dL)mmol/L [men or < 1.3 mmol/L (50 mg/dL)[women]; - OR triglycerides = 1.7 mmol/L (150mg/dL); or established on lipid-lowering treatment]
- •- strong family history of CVD (at least one parent, biological aunt/uncle or sibling with myocardial infarction or stroke aged < 60 years)
- •- duration of diabetes > 20 years
- •* defines as diagnosis below age 40 years AND insulin use within 1 year of diagnosis
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 450
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •- Women of child-bearing age (i.e. continuing menstrual cycle) not using effective contraception. For women of childbearing age in REMOVAL, acceptable forms of effective contraception include:*
- •* Established use of oral, injected or implanted hormonal methods of contraception
- •* Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- •[Consideration should be given to the type of device or system being used, as
- •there are higher failure rates quoted for certain types, e.g. steel or copper wire]
- •* Barrier methods of contraception: Condom or Occlusive cap (diaphragm or
- •cervical/vault caps) – must be combined with spermicidal
- •foam/gel/film/cream/suppository.
- •* Sole male partner has been sterilised with appropriate post-vasectomy
- •documentation of the absence of sperm in ejaculate.
- •* True abstinence: When this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, post-ovulation methods)
- •and withdrawal are not acceptable methods of contraception.
- •- Pregnancy and/or lactation; planning to get pregnant
- •- Patients with Acute Coronary Syndrome or Stroke/TIA within the last three months
- •- Symptomatic angina on mild or moderate exertion
- •- Stage 3 or 4 heart failure defined according to the NYHA criteria
- •- Estimated glomerular filtration rate < 45ml/min/1.73m^2
- •- Contraindications to metformin [hepatic impairment (ALT > 3.0 times ULN), known hypersensitivity to metformin, acute illness such as dehydration, severe infection, shock, acute cardiac failure, suspected tissue hypoxia]
- •- Metformin treatment for more than three months within the last two years
- •- Anaemia (haemoglobin <10.0 g/dL)
- •- Ongoing treatment with oral steroids, pramlintide or GLP-1 agonist therapy
- •- Hypoglycaemia unawareness confirme as significant by site Prinicipal Investigator
- •- Impaired cognitive function/unable to give informed consent
- •- Previous carotid surgery or inability to capture adequate carotid images
- •- Gastroparesis (on gastric emptying studies) confirmed as significant by site Principal Investigator OR more than two hospital admissions with unexplained vomiting in last year.
- •- History of biochemically-confirmed lactic acidosis (>5.0 mmol/L)
- •- Any coexistent life threatening condition including prior diagnosis of cancer within two years
- •- History of alcohol problem or drug abuse
- •- Diabetes or than Type 1 diabetes (e.g. secondary to pancreatitis, pancreatectomy or other primary pancreatic diseases)
- •- Involvement in a clinical trial involving an investigational medicinal product within the last six months
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