EUCTR2015-002387-16-IE进行中（未招募）1 期
The Role of Tetracyclines in the Personalised Management of MMP-9 and Cardiovascular Function in Type 2 Diabetes - Tetracyclines in the management of MMP-9 and cardiovascular function in diabetes
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- 性别
- All
入选标准
- •Treated Type 2 diabetes > 6 months
- •1562 C>T MMP-9 single nucleotide promoter polymorphism
- •Clinically stable (on same treatment for > 1 month)
- •Willing and able to provide informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1.Age < 18 years at the time of randomisation
- •2.Tetracycline hypersensitivity or other contraindications to minocycline therapy, e.g. use during pregnancy or breast feeding or obstructive oesophageal disorders such as stricture or achalasia.
- •3.Pre-menopausal women (defined as last menstrual period <12 months earlier). (i.e. postmenopausal women only will be eligible for enrolment. Postmenopausal is defined as 12 months with no menses without an alternative medical cause).
- •4.Change in diuretics within one month or recent admission for acute decompensated heart failure/cardiovascular event (e.g. ischaemia) < 3 months
- •5.Haemodynamically severe valvular heart disease
- •6.Evidence of significant inflammatory disease, connective tissue disease, hepatic disease, metabolic bone disease which may alter inflammation and parameters of matrix turnover and collagen metabolism
- •7.Hypertrophic, restrictive or constrictive cardiomyopathy
- •8.Clinically significant pulmonary disease as evidenced by hospitalisations or use of oral corticosteroids for pulmonary decompensation within 12 months, or requirement for home O2 or significant fibrosis
- •9.Severe anaemia (Haemoglobin <8.0g/dL)
- •10.Severe renal dysfunction (GFR < 30 mL/min/1.73m2)
- •11.Subjects with hepatic dysfunction (Any LFT > 3 Upper Limit of Normal)
- •12.Gastro-oesophageal reflux disease
- •13.Recent trauma or surgery (<6 months)
- •14.Malignancy
- •15.Systemic lupus erythematous (SLE)
- •16.Myasthenia gravis
- •17.Subjects with contraindications to MRI (NOTE: if a patient has a contraindication to MRI but is otherwise eligible for enrolment, they may be recruited onto the study. However, they will be excluded from undergoing MRI and this will be clearly highlighted in the patients CRF)
- •a.Hypersensitivity to gadolinium containing contrast agents
- •b.Brain Aneurysm Clip
- •c.Implanted neural stimulator
- •d.Implanted cardiac pacemaker or defibrillator
- •e.Cochlear implant
- •f.Ocular foreign body (e.g. metal shavings)
- •g.Other implanted medical devices: (e.g. Swan Ganz catheter)
- •h.Insulin pump
- •i.Metal shrapnel or bullet.
研究者
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